The Effect of an Educational and Supportive Intervention on Health Performance, Self-Efficacy and Maternal/Neonatal Outcomes in Pregnant Adolescents with presence of close relative as a continuous companion support: Study Protocol for a Randomized Controlled Trial (RCT)

doi:10.21203/rs.3.rs-4939969/v1

Background: Early motherhood (EM) has been identified as a major challenge for women's health in most developing countries and is associated with adverse outcomes in babies and mothers.

This study will examine the effect of educational and supportive intervention in pregnant teenagers and close relative as a Continuous Companion Support (CCS) on health performance, self-efficacy and maternal/neonatal outcomes.

Methods: The present protocol is introduced a parallel randomized clinical trial study with 136 adolescences pregnant woman under 19 years who will be randomly assigned to 2 groups (intervention and control group). Participants will be recruited from Comprehensive Health Service Centers (CHSCs) in Fasa city. The intervention group will receive six weekly sessions of educational and supportive courses.

Primary and secondary outcomes will be the assessed through the questionnaires (Self-Efficacy and Health Performance) and the maternal/neonatal outcomes, respectively. To follow the participants, we will evaluate the teenage pregnant by the follow up checklist to collect the data including participating in Educational/supportive courses, receiving complete routine care from CHSCs and presence of close relative as a CCS during pregnancy/labor, high-risk pregnancy symptoms, Apgar at first and 5Th minute, type of delivery, delivery complications. Data will be analyzed using SPSS software version 18. The level of significance in all tests have two-sided and 5%.

Discussion: The results of the present research could determine the appropriate method to increase Health Performance and self-efficacy in pregnant teenagers. It is obvious that the presence of close relative as a CCS improves the quality care of the teenage pregnant to reduces the Maternal/Neonatal complications and the costs borne by the pregnant teenagers and their families.

Trial registration: IRCT20230816059157N1 at 2023.08.28, prospectively registered.

Health Performance

General Self-Efficacy

teenage pregnancy

RCT

Adolescent pregnancy is still a big challenge in almost all countries, including developed and developing countries [1]. Teenage pregnancy can lead to complications, physical, mental disorders, and more infant mortality. These births are dangerous for both (mother and child). [2]. Compared to older pregnant women, pregnant teenagers experience complex psychosocial problems due to low self-esteem and stigma associated with teenage pregnancy[3]. Girls who get pregnant before the age of 15 die five times more than women who get pregnant at the age of 20–24 due to accidents related to pregnancy and delivery [4]. Although 11% of all births in the world are related to women aged 15–19, approximately 23% of problems related to pregnancy and childbirth occur in teenage mothers [5]

Currently, there are more than 1.2 billion teenagers in the world, 90% of whom live in developing countries[6, 7]. Among the key health issues, the International Conference on Population and Development (Cairo, 1994), which identified adolescents as a group with health rights and needs, noted that their fertility has been largely neglected.[8, 9].

According to the 2014 report of the WHO, 16 million pregnancies occur annually in girls aged 15 to 19, of which 2 million are in girls under the age of 15, and almost 90% of these pregnancies are in the context of marriage and almost half of them (49%) are unwanted[10, 11]. In addition, recent reports show that adolescents in low- and middle-income countries (LMIC) have about 21 million pregnancies per year., approximately 50% of which are unintended, resulting almost 12 million births.[12, 13] In the world, the birth rate of adolescent girls in 2023 was estimated at 1.5 per 1000 women, with higher rates in sub-Saharan Africa and Latin America/Caribbean with rates of (4.4) and (2.3) [14]. Although the pregnancy rate among Iranian teenagers is lower than the world average (approximately 7%) in the current situation, since the Islamic Republic of Iran has a high youth population [15]. Changes in population policy programs are predicted to change and increase teenage pregnancy rates by 2025[16, 17].

Few studies have been conducted regarding the quality of pregnancy care programs for adolescents, therefore, most clinic-based programs specifically designed to prevent teen pregnancies [18]. Currently, most of the research in the field of sexual-reproductive health in adolescence is focused on unmarried girls, and despite the large number of married adolescent women and many fertility problems in this group, research and planning and production of guidelines in this regard have been neglected[19].

Since studies show that several factors such as the quality of care, holding birth preparation classes, pregnancy care education, psychological support from relatives, painless childbirth exercises are effective in the outcome of pregnancy, [20] in this project in order to develop a teenager prenatal care, firstly, a systematic review was conducted to find out the special care programs for pregnant teenagers, and then a qualitative study was conducted to obtain the needs and requirements of teenage pregnancy, and finally, based on the routine prenatal care program in Iran, the teenager prenatal care was designed.

This protocol describes a single-blind clinical trial in which the designed teenager prenatal care program will be used.

Goals and Hypotheses

This study examines the effect of educational and supportive intervention on health performance, general self-efficacy and maternal/neonatal outcomes in pregnant adolescents.

According to the background presented, the specific objectives of this proposed study are:

Determine and comparison of the Health Performance score within intervention and control groups, before and after the intervention.

Determine and comparison of the General Self-Efficacy score within intervention and control groups, before and after the intervention.

Determine and comparison of the maternal and neonatal outcomes within intervention and control groups, before and after the intervention.

Trial design

In the present study will use a single-blind, single-center, parallel, randomized controlled trial (RCT) design. The total participants of 136 will be randomly allocated in a 1:1 ratio to the one intervention and one control groups. The intervention group will receive six weekly sessions of educational and supportive courses with the presence of pregnant teenagers and a close relative as a CCS. The participants in this study will be assessed in the baseline (t0 prior the intervention), immediately after the interventions (t1 at end of the sixth week), post-4 weeks after the end of intervention (t2 at end of the tenth week) and the time of delivery (t3 at when childbirth occurs). The control group will receive routine interventions. The research subjects are recruited from Comprehensive Health Service Centers (CHSCs). The number of woman recruited from any respective CHSCs will related to the total number of eligible teenage pregnant participants in each center. Individuals are evaluated by demographic questionnaire at the baseline of the study. In addition, they will be evaluated by the Self-Efficacy (GSE-17) and Health Performance (HPQ-II) questionnaires prior the intervention (t0) and after the intervention at t1-t3 intervals. Maternal and neonatal outcomes such as the presence of high-risk pregnancy symptoms, birth weight, Apgar and type of delivery will be recorded at the time of occurrence.

Interventions begin after baseline data collection. Participants will be trained with presence of their companion to receive full and continuous prenatal care and will be supported and encouraged them to contact the CHSCs for further assistance if needed. In addition, educational materials were provided to them. A virtual group will also be formed in order to provide educational materials and to answer questions and to follow up the participants.

This study protocol was designed and reported based on the Consolidated Standards of Reporting Trials (CONSORT) statement (Figure 1, Table 1([21].

Participants’ eligibility

The research population includes all teenage pregnant with these Inclusion and Exclusion criteria and living in Fasa city who refer to the urban CHSCs.

Inclusion criteria

- Adolescent 10-19 years’ old

- Interested in participating in the study

- Married

- Pregnant

- Primiparous

- Gestational age between 18-24 weeks

- Referral to comprehensive health service centers / teaching hospitals in Fasa and its provinces

- Ability to speak and understand Farsi language

- No history of depression and mental disorders

- Not having chronic physical diseases

- Not abusing drugs

- Informed consent to participate in the research project

Exclusion criteria

- Prohibition of physical exercises

- Receiving special medicine due to physical or psychological problems

- Simultaneous/recent participation in other educational/treatment programs

- Failure to participate in at least two sessions of course classes

Participants’ recruitment

The researcher will be responsible for recruiting participants and assisting them to provide informed consent and information. The researcher will screen potentially eligible participants based on demographic and medical history. People who meet the mentioned criteria are invited to participate in the study.

Table 1. List of initial and follow-up evaluation courses in the study
variables	Enrolment	Baseline	follow-up assessment (weeks)
variables	Enrolment	Baseline	6^th	10^th	delivery
Eligibility screen
Health performance questionnaire (HPQ-II)		*	*	*
General self-efficacy questionnaire (GSE-17)		*	*	*
High-risk pregnancy symptoms €	*	*	*	*	*
Birth weight					*
Birth height					*
Birth head circumference					*
Delivery complications ¢					*
Participating in Educational/supportive courses			*
Receiving the routine care of the CHSCs		*	*	*	*
Having a close relative as a CCS		*	*	*	*
Apgar first minute					*
Apgar, the fifth minute					*
Type of delivery					*
Demographic information ¥	*
Follow-up checklist £			*	*	*
¥ Demographic information including age, menstrual age, age of marriage, duration of marriage, spouse's age, education, place of residence, spouse's education, spouse’s occupation, economic conditions, having a messenger, past medical history. £ The follow-up checklist includes: Questions such as participating in Educational/supportive courses, complete routine care of the CHSCs and having a close relative as a CCS during pregnancy/labor, high-risk pregnancy symptoms, Apgar at first and 5^TH minute, Type of delivery, Delivery complications. € High-risk pregnancy symptoms: chest pain /continues abdominal pain /decreased or no fetal movement /extreme fatigue/fainting or lightheaded /heart palpitations/severe headache /nausea and vomiting/trouble in breathing /swelling and redness, pain in limbs/vaginal bleeding and discharge[22] ¢ Delivery complications: gestational diabetes/high blood pressure/ preeclampsia /preterm labor/ loss of pregnancy (miscarriage)[23]

Randomization

We will ask a biostatistician to generate the randomization sequence. Allocation of participants to two groups (one intervention and one control groups) will perform via randomization and it will be done through the randomizer software. (www.randomizer.org).

Method of concealment

Allocation concealment will be done centrally. In such a way that the sequence of allocation will be in the hands of someone outside the research team, and as each person enters the study, the researcher will contact the desired person and assign the person to the desired group.

Blinding

The main researcher will be blinded to the participant’s characteristics and the group they allocated to. Participants would be aware of the type of intervention, therefore, it is not possible for them to be blind. In this study, the allocation of the subjects to the intervention and control groups remains hidden for the main researcher and the methodological analyst, and the person who performs the analyses does not know about the group of subjects either.

Intervention

The interventions consist of six educational weekly sessions. Planned interventions will be implemented in the intervention group subsequent the completion of the sample recruitments. Program summary as follow:

According to systematic review conducted in the field of teenage pregnancy and the qualitative study on health care workers and adolescence mothers regarding their experiences and needs as part of the present project (submitted and under reviewed document) and to according to the national program of prenatal care, we summarized and prepared the resulting data to be reviewed by a group of experts for the type and quality of educational/supportive contents of the intervention. The expert panel was included from Gynecology and Obstetrics, Reproductive Health, Psychiatry, Epidemiologist, community medicine, Planning & Policy Making, Master's Degree in Midwifery Consultation and Midwifery.
After holding the expert panel meetings, the educational/supportive content of the intervention was released for at least six weekly sessions. Table 2 shows the content of each sessions of educational/supportive intervention.
In the control group, routine interventions are performed and the general health promotion booklet for the pregnancy care is provided to them. A defined contact number will be provided to the treatment companions so that they could contact researcher in case of any questions or problems.

Table 2: Content and quality of each sessions of educational/supportive intervention.
Place of sessions: Vali Asr Hospital Conference Hall Fasa city
Participants: teenagers in 18-24 weeks of gestational age and a close relative as a CCS
Time: Every Wednesday 11-13
Sessions	Time of session	Subjects	objectives
Session 1	90 min	Explaining and introducing the goals of the educational/supportive sessions for pregnant teenagers and their close relatives as a CCS (initial conversation and establishing communication, provide a safe environment, explaining the goals, checking the current situation and conditions and expressing feelings and emotions)	Introducing each other and explaining the goals of the program
Session 2	120 min	Changes inpregnancy (skin, breasts, urinary system، respiratory system, digestive system، cardiovascular system ( Pregnancy complications like: (nausea and vomiting in the morning, fatigue, increased vaginal secretions, swelling, varicose veins, leg cramps) Personal hygiene (bathing, wearing dental care clothes, traveling, working, resting, exercising, sexual relations, addiction, smoking, taking medicine) Risky symptoms in pregnancy Mental health in pregnancy Preparation for motherhood Desired supportive care from family members and requiring the presence of a close relative as a constant companion*	Body changes and adaptations during pregnancy/ General Preparation / family supportive care
Session 3	120 min	Prenatal care Familiarity with some pregnancy diseases (diabetes, preeclampsia) The health of the fetus during the weeks of pregnancy Body position during pregnancy Nutrition during pregnancy Food groups, consumption of food supplements Caffeine consumption Sex in pregnancy Mood changes in pregnancy Characteristics of vaginal secretions in pregnancy Self-care for ligament pain, back pain, leg cramps, carpal tunnel syndrome Self-care for skin cracks, skin spots, varicose veins, non-pathologic edema Self-care in heartburn Dental care	Self-care/Diet
Session 4	90 min	Methods to reduce labor pain Planning for childbirth Postpartum recovery period Postpartum risky symptoms Postpartum follow up	Labor / Postpartum care
Session 5	120 min	Pregnant stretching/breathing exercises Relaxation/benefits of massage Postpartum exercises Characteristics of the baby at birth The first hour/baby's first skin to skin contact/first feeding Benefits of mother and baby roommates Newborn vaccination Screening	Relaxation in pregnancy /post-partum exercises /newborn care
Session 6	120 min	Preparing the baby for transfer home The emotional perception with the baby Characteristics of a healthy baby Benefits of breastfeeding for baby/mother Signs of proper breast feeding Hug care of mother and baby (kangaroo method) Clothes, bed and sleeping position of the newborn. How to change diapers, how to bathe, how to cut nails Baby massage Maternal nutrition during breastfeeding	Home care/breast feeding benefits/baby massage
*The presence of a close relative as a constant companion is mandatory for pregnant teenagers.

Training sessions will be held by the researcher in the hospital management conference hall located on the first floor of Vali Asr Hospital. Vali Asr Hospital is a governmental medical center located in the middle of the city, equipped with an elevator and a suitable space for parking cars. In addition to face-to-face meetings, educational materials will be provided to them. Also, a virtual group on the web will be formed to provide educational materials and answer questions and follow up the participants. The presence of pregnant teenagers and a close relative as a constant companion in all training/support sessions is mandatory.

Measures

The data collection tools in this research are:

General Self-Efficacy Questionnaire (GSE-17):

This scale was created by Scherer et al. in 1982 to determine the different levels of self-efficacy of people. GSE-17 has 17 questions for general self-efficacy assessment. Scherer mentions the validity calculated according to Cronbach's alpha coefficient for general self-efficacy as 0.76 [24].

Bakhtiari Barati in 1997 to measure the construct validity of the general self-efficacy scale, the scores obtained from this scale were compared with the measures of several personality traits (Rather's internal and external control scale, personal control subscale, Marlow and Karan's social degree scale, and the competence scale between Freddie Rosenberg) correlated that the predicted correlation between the self-efficacy scale and the dimensions of personality traits was moderate (0.61 and significant at the 0.05 level) and was in the direction of confirming the desired structure. Sherer et al.'s general self-efficacy questionnaire has 17 questions. Each question is set on a 5-point Likert scale ranging from strongly disagree to strongly agree. The score of each is as follows: totally disagree 1, disagree 2, moderate: 3, agree: 4, totally agree: 5, the scoring of the scale is such that each item is awarded from 1 to 5 points. Questions 1, 3, 8, 9, 13, and 15 are scored from right to left and the rest of the questions are scored in reverse, from left to right. Therefore, the maximum score that a person can get from this scale is 85 and the minimum score is 17. The validity and reliability of the questionnaire in Barati Bakhtiari's research is 79% [25]. Also, 82% has been proven in rugby research. Therefore, this scale is statistically justifiable[26].

Health Performance Questionnaire (HPQ-II):

In 2003, a 34-item questionnaire (HPQ-II) was developed by Lindgren. It measures the adequacy of health practices in the six sub-categories of balanced rest and exercise, prevention of illness and injury, care for nutrition and diet, avoidance of drugs, and acquisition of knowledge about pregnancy and childbirth. Items are scored on a five-point Likert scale, including "never" (score 1), "rarely" (score 2), "sometimes" (score 3), "often" (score 4) and "always" (score 5). be. (Total score range: 170-34). Higher scores indicate better hygiene practices by mothers. [27]. The reliability of the Persian version of the tool was confirmed in a study in Sirjan-Iran (2013) with intraclass correlation coefficient (ICC) and Cronbach's alpha coefficient of 0.81 and 0.83, respectively [16, 28]

Demographic questionnaire:

Variables such as age of the participant, menstrual age, age of marriage, duration of marriage, spouse's age, education, place of residence, spouse's education, spouse’s occupation, economic conditions, having a messenger, medical history will be asked[29].

Birth weight, birth height and birth head circumference (HC)

The planning will be such that all births will be occurred at hospital. The trained midwifes will be visited neonates to record measurements at “day of birth”. Weight will be measured to the nearest 2 g on a digital scale (Seca 727, Hamburg, Germany), which will be checked before each weighing against standard weights. [30]. Neonatal recumbent length from top of the head to the heel of one foot will be measured to the nearest 5 mm on a length board HC will be measured to the nearest 0.1 cm by a tape line[31].

Apgar score. (1 and 5 minute)

It scores five items (respiration, heart rate, muscle tone, reflexes and color) between 0 and 2, to give a total score out of 10 and it taken at the first and fifth minute after birth. Admission of the neonate to an intensive care unit and resuscitation in the delivery room were classified as yes or no[32].

Place of study

Fasa city, located in Fars province in southeast of Iran (Figure 2). Participants will be selected from CHSCs located in this city.

Sample size calculation

According to the objectives and type of the study and referring to the previous studies [29] and also based on assumptions: 5% error and 80% power and average difference of about 1.5( standard deviation 3.08 in the control group) and using the considering the item of motherhood and pregnancy attitude (one of the items to reach the minimum sample size required. This item is the most important goal and has the largest sample size that covers other goals as well (following formula 68 people were estimated in each group. In the above formula, the values of z are fixed and equal to the 97.5 percentile and the 80th percentile of the standard normal distribution.

Follow up

Both groups will be evaluated by demographic, GSE-17 and HPQ-II questionnaires in the baseline, 6^Th and 10^Th weeks of the study and time of delivery.

Interventions begin after baseline data collection. Subjects will be promoting to participate in an at least 15-minutes interview via social media weekly about needs and questions. In addition, the principal investigator will be available in case of any problems or questions.

To follow the participants, we will evaluate the teenage pregnant by the follow up checklist to collect the data including participating in Educational/supportive courses, receiving complete routine care from CHSCs and presence of close relative as a CCS during pregnancy/labor, high-risk pregnancy symptoms, Apgar at first and 5^Th minute, type of delivery, delivery complications.

Data collection and management

This study will meet the CONSORT guideline to recruit, evaluate and report the findings of the participants.

All participants who registered to the study (based on the order of their entry), will be assigned to a unique ID. The data will be collected via the online system link directly into the database. The platform used to design the questionnaires will be porslin.ir. The data will be saved at SHMU data set. Online data gathering will enable the researchers to access and monitor the data ongoing. The progress of the research will be shared to the SHMU monthly. It should be noted that the researcher keeps the research notes for a period of 5 years after the publication of the study results.

Validation

Questionnaires used in this research have been translated and validated. (Self-efficacy questionnaire (GSE-17)[25, 26] and Health performance questionnaire (HPQ-II)[16, 28].)
The educational materials will be validated using expert panels.

Planned statistical analyses

Reporting the data of this research at baseline (t0), immediately after the interventions (sixth week) (t1), post-4 weeks after the intervention (tenth week) (t2) and the time of delivery (t3) will be done. This study will apply the intention-to-treat approach to assess the primary and secondary outcomes. Subjects who completed baseline (t0) were included in the analyses. If a participant decides to leave the study, the researchers will monitor their symptoms and their main outcomes.

Data privacy, protection, security and access

To ensure anonymity and confidentiality we will be use an ID code. In addition to identifying the participants, this ID will be used to identify the group they belong to. In any case, the respondents' demographic information will never be directly connected to their clinical information. The researcher is responsible for maintaining the safety of the data and this issue will be announced to all participants through the researcher. All codes, notes or files containing demographic information are stored on only one secure computer.

Outcomes

Primary outcome

Self-Efficacy Questionnaire (GSE-17) and Health Performance Questionnaire (HPQ-II) will be assessed in baseline and 6^th (immediately after the interventions) and 10^th (post-4 weeks after the intervention) weeks as primary outcome.

Secondary outcome

The maternal and neonatal outcomes such as high-risk pregnancy, birth weight, Apgar in firs and 5^Th minutes and type of delivery will be assessed as the secondary outcome at the time of delivery.

Statistical analysis

In this study, the data at the beginning, and 6th (immediately after the interventions) and 10th (post-4 weeks after the intervention) weeks and in the time of delivery will be reported and the data of the interventions will be compared to specify any significant differences between control and intervention groups.

Data will be analyzed using SPSS software version 18 (SPSS Inc, Chicago, IL, USA. In this study, descriptive statistical methods including central and dispersion indices were used to describe the data and statistical significance tests will be used to analyze the data. Mean and standard deviation for quantitative variables and number and percentage for qualitative variables will be used, respectively. The normality of the data will be determined using the Shapiro-Wilk test and the combined indices of skewness and kurtosis. For inferential analysis and between-group analysis, chi-square significance test or Fisher's exact test, independent t-test, and variance analysis with repeated measures will be used. In the intra-group analysis, the significance test of analysis of variance with repeated measures and Cochran's test will be used. If the assumptions of the chi-score test were not met, Fisher's exact test will be used, and if the data had a serious deviation from the normal distribution, the Mann-Whitney U test will be used. The level of significance in all tests will be two-sided and 5%.

Adverse event reporting and harms

Possible damages and complications of participating in this study are as follows:

Since the intended intervention in this research is educational, in case of any question or problem, the participants can contact the person in charge of the research.

Constraints

This document presents the study protocol of a parallel randomized clinical trial in real form. The current study also has operational limitations, such as the fact that the study subjects were pregnant teenagers who lived in areas with limited access, limited transportation facilities, and communication networks, leading to sample loss.

Dissemination

The study protocol and intervention results will be published by the peer-reviewed manuscripts. Both manuscript and abstract will be referred to all co-investigate colleagues for review of its appropriateness and scientific quality and accountability before submission. The manuscript will be received permission from the SHMU before publication.

Outlook

The results of this research can be used by researchers in the future research. Also, physicians, specialists in the fields of gynecology, sexual and reproductive health, midwifery and medical sciences, and organizations related to teenage pregnancy can use the results of this research properly. The correct application of evidence and research findings leads to the improvement of the quality of care during pregnancy. Using the results of this research and others like it in pregnant teenagers will help to reduce the burden of pregnancy and childbirth complications in the society.

Ethical considerations

This study will be conducted in compliance with the ethical principles related to the Declaration of Helsinki. [33]. The protocol is approved by the Research Ethics Committee of SHMU with the code number (IR.SHMU.REC.1401.105) and registered at IRCT.IR; Clinical Trial of Iran IRCT20230816059157N1.

Few studies have been conducted regarding the quality of pregnancy care programs for adolescents [18]. as well as the lack of a comprehensive program of prenatal care for this high-risk group, in which we have shown in systematic reviews, they are the main necessities of conducting this study.In the present study, we will show that the prenatal care program for adolescents will lead to reduce the complications during pregnancy and delivery by improving the health and self-efficacy of pregnant adolescents, and other studies have also shown that Health Performance It plays an important role in reducing the complications of pregnancy and childbirth in teenagers by reducing the related risk factors [34]. educational and supportive services provided training to improve the health behaviors of adolescent mothers[35]. Self-efficacy plays an important role in coping with labor and labor pain and can affect people's motivation and attitude. For natural births, women who are more confident in their ability are associated with less pain during labor and, subsequently, less use of pain medication during labor[36, 37]. In this study, the pregnancy care training program for pregnant adolescents and their companions will be increased the health performance score and increased the self-efficacy of pregnant adolescents and reduce maternal/neonatal complications.

Continuous Companion Support (CCS)

Early motherhood (EM)

Comprehensive Health Service Centers (CHSCs)

low- and middle-income countries (LMICs)

Self-Efficacy (GSE-17) and Health Performance (HPQ-II)

Consolidated Standards of Reporting Trials (CONSORT)

Interclass correlation coefficient (ICC)

head circumference (HC)

identification data (ID)

Trial status

Necessary permits were obtained and the recruitment of samples began. 139 qualified participants were invited to participate in the research and the intervention began.

Authors’ contributions

FN, SMM, ShS and AK equally contributed to the conception and design of this research; SMM, ShS and AK contributed to the design of this research; SMM and ShS contributed to Plan for acquiring and analysis of the data; FN, SMM and ShS will contribute to the interpretation of the data; FN and SMM drafted the preliminary manuscript and SMM prepared the final manuscript along with SMM who was responsible for manuscript editing. All authors critically revised the manuscript, agreed to be fully accountable for ensuring the integrity and accuracy of the work, and read and approved the final manuscript to be published. All authors met the criteria for authorship and that all entitled to authorship were listed as authors in the title page.

Funding

No financial support for disseminating the protocol.

Availability of data and materials

The data that support the findings of this study are not openly available due to reasons of sensitivity and are available from the corresponding author upon reasonable request. https://shmu.ac.ir/chsbsr/fa/page/1655/%D8%B1%D8%A6%DB%8C%D8%B3-%D9%85%D8%B1%DA%A9%D8%B2

Ethics approval and consent to participate

The research proposal was approved by the Research Review Board affiliated with Shahroud School of Nursing and Midwifery. Also this study will be conducted in compliance with ethical principles outlined in the Declaration of Helsinki. The protocol is approved by the Research Ethics Committee of Shahrod University of Medical Sciences (SHMU) with the code number

(IR.SHMU.REC.1401.105) and registered at IRCT.IR; Clinical Trial of Iran; IRCT20230816059157N1. The protocol follows the Standard Protocol Items: Recommendations for Interventional Trials guidelines and the CONSORT statement.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Acknowledgements

The authors appreciated Vice-Chancellor for Research of Shahroud Universities of Medical Sciences.

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No competing interests reported.

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The Effect of an Educational and Supportive Intervention on Health Performance, Self-Efficacy and Maternal/Neonatal Outcomes in Pregnant Adolescents with presence of close relative as a continuous companion support: Study Protocol for a Randomized Controlled Trial (RCT)

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Methods/ design