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IRCT20220501054711N1 IRCT 2022-05-10 Ahvaz University of Medical Sciences Implementing and evaluation labor and delivery management program using the world health organization safe childbirth checklist :An Embedded mixed-method study Comparison of the Effectiveness of management of labor and delivery with using training on evidence-based cares based on the world health organization safe childbirth checklist and routine performance on maternal and neonatal outcomes 2022-06-05 anticipated 944 Complete https://irct.ir/trial/63335 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: This study will be a Stratified randomized controlled trial across eligible governmental hospitals in Ahvaz. four eligible hospitals will be identified. We will match hospitals (i.e.strata) according being educational or not, so that We will have an educational hospital and a non- educational hospital in each strata. Due to the fact that randomization will be performed on the basis of hospitals, not individually, the women admitted in each of these hospitals will be assigned to only one intervention group. 236 eligible pregnant women will be enrolled in each of the hospitals and this will be continued until we can gain the final sample size in each center. Sampling of pregnant women will be done in convenience non -probability. N/A Normal vaginal Delivery Management. Intervention 1: Intervention group: In intervention groups, the Labor and delivery program management will be based on evidence-based care in accordance with the World Health Organization safe childbirth checklist. In these hospitals, the researcher will give the necessary training of labor and delivery management program based on evidence-based care standards in according to the safe childbirth checklist to all care providers (midwives, residents, gynecologists) who work in labor and delivery ,the operating room and postpartum ward. These trainings will be done in groups of ten over several three-hour sessions, so that all care providers will be able to participate in these sessions. Training will be in the form of lectures, training booklets and practical simulations. After training in the intervention hospitals, volunteer care providers to participate in the trial, will manage labor and delivery according to the mentioned program . In order to reduce the probability of error in the study, the people evaluating the maternal and neonatal consequences will be different from the people in the research group. Four evaluators (midwives with 5 to 7 years of Work experience) will receive the necessary training by the researcher during two, two-hour training sessions on how to assess maternal and neonatal outcomes. To reduce the error of bias by the evaluators, they do not have any employment cooperation in the mentioned hospitals. Initially, according to the data quality assurance protocol, the researcher will evaluate the maternal and neonatal outcomes with the evaluators until each evaluator achieves 100% accuracy and compliance with the standard in the evaluation of maternal and neonatal outcomes. Then they will follow up maternal and neonatal outcomes independently in intervention and control hospitals. Neonatal outcomes up to 7 days and maternal outcomes up to 42 days after delivery will be followed up and compared in both groups. Intervention 2: Control group: current position. Yes - There is a plan to make this available What will be shared: The data of this study will be accessible upon the request form the corresponding author after publication, or we may deposit our data in the “Figshare” for sharing with other researchers after the publication of the manuscript. When: The data will be accessible upon the request from the corresponding author or in the Figshare” after publication of the manuscript (we anticipate this time by the end of 2023). To whom: Our data will be accessible upon the request from faculty members who interested to use our data with the research purpose (with acknowledgement of authors in our study) Conditions: Interested researchers can send an e-mail to the corresponding author and request our data. In case of if we deposited our data in the “Figshare” cite, they will be accessible from the cite Where to obtain: Mina Iravani-Iran, Ahvaz, Golestan Ave, Ahvaz Jundishapur University of Medical Sciences, Nursing & Midwifery School, Midwifery Department How to obtain: The requested information will be sent at the most up to one week after receiving the email Comments:
public Atefeh Kamrani
Jundishapur medical university, Farvardin street, Gorleston Blvd
Ahvaz Iran (Islamic Republic of) 15794-61357 +98 61 3336 2414 atykamrani@yahoo.com Ahvaz University of Medical Sciences scientific Dr. Mina Iravani
School of Nursing and Midwifery, Jundishapur University of Medical Sciences, Farvardin street, Golestan Blvd
Ahvaz Iran (Islamic Republic of) 15794-61357 +98 61 3373 8538 minairavani2004@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) All care providers who are responsible for caring for women who have been admitted for childbirth Pregnant women who have inclusion critria All Pregnant women who have singleton pregnancy and with gestational age 37 weeks or over with any ages, ethnicity, any history of obstetrics and any number of deliveries, who are admitted for vaginal delivery no limit no limit Female Reluctance to participate in the trial O80 Single spontaneous delivery N/A N/A Intervention group: In intervention groups, the Labor and delivery program management will be based on evidence-based care in accordance with the World Health Organization safe childbirth checklist. In these hospitals, the researcher will give the necessary training of labor and delivery management program based on evidence-based care standards in according to the safe childbirth checklist to all care providers (midwives, residents, gynecologists) who work in labor and delivery ,the operating room and postpartum ward. These trainings will be done in groups of ten over several three-hour sessions, so that all care providers will be able to participate in these sessions. Training will be in the form of lectures, training booklets and practical simulations. After training in the intervention hospitals, volunteer care providers to participate in the trial, will manage labor and delivery according to the mentioned program . In order to reduce the probability of error in the study, the people evaluating the maternal and neonatal consequences will be different from the people in the research group. Four evaluators (midwives with 5 to 7 years of Work experience) will receive the necessary training by the researcher during two, two-hour training sessions on how to assess maternal and neonatal outcomes. To reduce the error of bias by the evaluators, they do not have any employment cooperation in the mentioned hospitals. Initially, according to the data quality assurance protocol, the researcher will evaluate the maternal and neonatal outcomes with the evaluators until each evaluator achieves 100% accuracy and compliance with the standard in the evaluation of maternal and neonatal outcomes. Then they will follow up maternal and neonatal outcomes independently in intervention and control hospitals. Neonatal outcomes up to 7 days and maternal outcomes up to 42 days after delivery will be followed up and compared in both groups. Control group: current position Mother’s satisfaction of delivery. Timepoint: Before discharging of hospital. Method of measurement: Mackey Childbirth Satisfaction Rating Scale. Mother’s experience of delivery. Timepoint: 4-6 weeks after delivery. Method of measurement: childbirth experience questionnaire 2/0. Type of delivery. Timepoint: After of delivery. Method of measurement: Observation and record in check list. Apgar score below 7. Timepoint: At 1 and 5 minutes after birth. Method of measurement: Observation and examination. Frequency of newborn admission to neonatal ward or NICU. Timepoint: After of delivery. Method of measurement: Observation / record in check list. Shoulder dystocia. Timepoint: During delivery. Method of measurement: Observation and record in check list. Postpartum hemorrhage. Timepoint: after of delivery. Method of measurement: Increased maternal pulse rate above 110 beats per minute and maternal systolic blood pressure less than 90 mm Hg with vaginal bleeding. Hematocrit will be measured at baseline and then 8 hours after delivery. Maternal infections. Timepoint: During labor and delivery up to 42 days after delivery. Method of measurement: Sublingual temperature of 39 degrees or more or between 38-39 degrees that persists after 30 minutes Examination/ record in check list. Frequency of third and fourth-degree perineal lacerations. Timepoint: After of delivery. Method of measurement: Observation and record in check list. Near miss morbidity. Timepoint: From the time of hospitalization until 42 days after delivery. Method of measurement: Based on cardiovascular, pulmonary, renal, hepatic and uterine dysfunction. Ahvaz University of Medical Sciences Approved 2022-04-16 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Ethics committee of Ahvaz Jundishapur University of Medical Sciences, Farvardin street, Gorleston Blvd Ahvaz Khouzestan Iran (Islamic Republic of)