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IRCT20100414003706N41 IRCT 2022-04-30 Tabriz University of Medical Sciences Effect of continuous care model from pregnancy to postpartum by midwifery students The effect of implementing the continuous care model by midwifery students during pregnancy, childbirth, and postpartum on childbirth experience, fear of childbirth, and postpartum depression 2022-06-25 anticipated 92 Complete https://irct.ir/trial/62761 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Participating pregnant women will be randomized into two groups, receiving continuous care by midwifery students or control. The allocation sequence will be generated by a person not involved in the recruitment and data collection through stratified (based on 1st or 2nd-3rd birth order) block randomization with randomly varied block sizes of four and six, and an allocation ratio of 1:1 using a computer program. Central allocation (phone) will be used for the allocation concealment. Simple randomization will be used to determine the sequence of assigning the participating women to midwifery students. Two pregnant women will be assigned to each student (as primary caregivers) and each student will support another student who provides care for two other women. N/A Condition 1: Fear of childbirth. Condition 2: Postpartum depression. Condition 3: Childbirth experience. Intervention 1: Intervention group: Continuous care will include the following:1. Receive at least twice face-to-face care (between 26-29 weeks and between 35-36 weeks of pregnancy), ۲. Telephone or video consultations (at least four consultations with intervals of 7-10 days between two face-to-face care sessions and then weekly until delivery), 3. Attending a woman's bedside and providing care during labor and delivery up to 2 hours after delivery, 4. Face-to-face visit 24-12 hours after delivery in the hospital, 5. Giving at least three telephone or video consultations (3-5 days, 7-10 days and 20-30 days) after delivery, 6. Giving students' mobile numbers to women to answer possible non-emergency questions (from 8 am to 11 pm) and emergency questions and delivery information (24 hours a day, 7 days a week), 7. Additional face-to-face or online care will also be provided by the students during pregnancy or after delivery. Intervention 2: Control group: Control group: will receive their usual pregnancy, childbirth, and postpartum care in health centers and hospitals. This group of mothers will also receive free online counseling from six weeks (end of follow-up on the impact of the intervention) to six months after delivery by the Ph.D. student in midwifery who owns the dissertation. Yes - There is a plan to make this available What will be shared: All deidentified IPD can be shared. When: Starting soon after the publication of the study results. To whom: Data will be available for researchers working in academic institutions, as well as to the chief editor and reviewers of the submitted manuscript. Conditions: The data will be available to researchers upon request and submission of the proposal to perform a meta-analysis using IPD. Also, in exceptional cases, data will be made available to the chief editor of the journals for checking. Where to obtain: Refer to the email addresses (alizades@tbzmed.ac.ir) How to obtain: The requests should be sent by email and data will be available within two weeks. Comments:
public Elham Jafari
Tabriz- South Shariati St. School of Nursing & Midwifery
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3475 3906 elhamdjafari@gmail.com Tabriz University of Medical Sciences scientific Sakineh Mohammad-Alizadeh-Charandabi
Faculty of Nursing & Midwifery, South Shariati
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3477 2699 alizades@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Gestational age 26 to 29 weeks based on LMP or under 12- week ultrasonography Single pregnancy Maximum history of two birth No known underlying disease before pregnancy No history of high-risk pregnancy Have a minimum of secondary education Willingness to give birth in hospitals affiliated with Tabriz University of Medical Sciences or Tabriz Social Security Hospital no limit no limit Female History of cesarean section Willingness to elective cesarean section No access to smartphones and the internet Known major abnormalities in the fetus Occurrence of any stressful events (such as divorce, death of first-degree family members, and diagnosis of an incurable disease for a family member) in the last three months Simultaneous participation in another trial F40.232 F32.8 Fear of other medical care Other depressive episodes Prevention N/A Intervention group: Continuous care will include the following:1. Receive at least twice face-to-face care (between 26-29 weeks and between 35-36 weeks of pregnancy), ۲. Telephone or video consultations (at least four consultations with intervals of 7-10 days between two face-to-face care sessions and then weekly until delivery), 3. Attending a woman's bedside and providing care during labor and delivery up to 2 hours after delivery, 4. Face-to-face visit 24-12 hours after delivery in the hospital, 5. Giving at least three telephone or video consultations (3-5 days, 7-10 days and 20-30 days) after delivery, 6. Giving students' mobile numbers to women to answer possible non-emergency questions (from 8 am to 11 pm) and emergency questions and delivery information (24 hours a day, 7 days a week), 7. Additional face-to-face or online care will also be provided by the students during pregnancy or after delivery. Control group: Control group: will receive their usual pregnancy, childbirth, and postpartum care in health centers and hospitals. This group of mothers will also receive free online counseling from six weeks (end of follow-up on the impact of the intervention) to six months after delivery by the Ph.D. student in midwifery who owns the dissertation. Childbirth experience score. Timepoint: 40 to 50 days after delivery. Method of measurement: Childbirth Experiences Questionnaire vsersion 2.0 (CEQ2.0). Postpartum depression score. Timepoint: 50-40 days after delivery. Method of measurement: Edinburgh Postnatal Depression Scale (EPDS). Fear of childbirth score. Timepoint: Baseline (before randomization), 35-36 weeks of pregnancy, 50-40 days after delivery. Method of measurement: The Wijma delivery expectancy/experience questionnaire (W-DEQ-A and B). Fear of childbirth score (during pregnancy). Timepoint: Baseline (before randomization), 35-36 weeks of pregnancy. Method of measurement: The Wijma delivery expectancy/experience questionnaire (W-DEQ-A). Pregnancy depression score. Timepoint: Baseline (before randomization), 35-36 weeks of pregnancy. Method of measurement: Edinburgh Postnatal Depression Scale (EPDS). Childbirth satisfaction score. Timepoint: 12 to 24 hours after delivery. Method of measurement: Maternal satisfaction in normal and caesarean birth (SMMS-normal birth and SMMS- caesarean birth). Score for receiving support and control. Timepoint: 12 to 24 hours after delivery. Method of measurement: Support and Control in Birth (SCIB). Score of experiences of maternity care. Timepoint: 40-50 days after delivery. Method of measurement: Women’s experiences of maternity care (EMC). Breastfeeding self-efficacy score. Timepoint: 40-50 days after delivery. Method of measurement: Breastfeeding Self-efficacy Scale (BSES). Type of delivery. Timepoint: After delivery. Method of measurement: Checklist (vaginal/cesarean). Duration of hospitalization until delivery. Timepoint: 12-24 hours after delivery. Method of measurement: Mother's hospital record. Infant's fifth-minute APGAR. Timepoint: 12-24 hours after delivery. Method of measurement: Infant's hospital record. Change in hematocrit between before and after delivery. Timepoint: At the time of admission of the mother in the hospital and 12-24 hours after delivery. Method of measurement: Measurement of blood hematocrit at laboratory of the hospital. Tabriz University of Medical Sciences Approved 2021-04-19 Ethics committee of Tabriz University of Medical Sciences No. 2 Central Building, Tabriz University of Medical Sciences, Golgasht Ave., Tabriz, Iran Tabriz East Azarbaijan Iran (Islamic Republic of)