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IRCT20230620058548N1 IRCT 2023-08-29 Tehran University of Medical Sciences Comparison of maternal and neonatal outcomes in caring by Doula, trained lay companion and routine midwifery care Comparison of maternal and neonatal outcomes in caring by Doula, trained lay companion and routine midwifery care : A Quasi-Experimental Study 2018-07-21 anticipated 150 Complete https://irct.ir/trial/72193 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In the accompanying group trained to select samples, we entered the SIB system in 10 selected health centers in Arak city and extracted the list of pregnant mothers who met the criteria for entering the study, and then the mothers were asked to enter the study and those who agreed were randomly selected. became A simple random sampling method was used to select the mothers of these centers. We had a list of all the mothers of this center (from 1 to 389), then using Excel, a number was randomly generated for each mother, and the required 50 samples (from number 1 to 50) were taken. The group of doulas were selected from midwife counseling centers and compassionate midwives using available sampling method. 62 mothers who registered for doula from July 2017 to June 2018 were selected from Taleghani, Sina and Imam Khomeini (RA) hospitals. A simple random sampling method was used to select the mothers of this group as well as the companion group. After presenting a list of all the mothers of this center (from 1 to 62), we randomly generated a number for each mother using Excel. This study was initially designed as a randomized trial, but when we reached the sampling stage, we realized that due to the small number of centers and the small number of mothers who want to receive support from midwives, it is not possible to randomly allocate the samples in groups. Differently, the study was conducted in a semi-experimental manner, so that only random sampling was done. But the allocation of samples to groups was not done randomly. The samples of the control group were mothers who referred to Taleghani Hospital for prenatal care. From September 1397 to Mehr 1397, like the Dola group and the companion group, we used simple random sampling to select the mothers of the control group, based on which a list of all the mothers of this hospital who met our criteria (from 1 to 95) was presented, then we A number was randomly generated for each mother using Excel and 50 samples (numbers 1 to 50) were taken from 95 mothers. N/A Condition 1: Active phase duration. Condition 2: Second stage duration. Condition 3: Satisfaction with childbirth. Condition 4: Anxiety during labor. Condition 5: Duration of skin-to-skin contact. Condition 6: Severity of labor pain. Condition 7: Time to start breastfeeding. Condition 8: Apgar score in the first and fifth minutes of birth. Condition 9: Time to start skin-to-skin contact. Condition 10: Duration of skin-to-skin contact. Condition 11: How to contact mother and infant. Intervention 1: Intervention group: Care by doula: The samples of the care group were selected by accompanying midwives from private midwifery service centers. The accompanying midwife was also one of the staff of the center who personally undertakes all care services within the scope of duties of the accompanying midwife in labor, but the delivery was performed by the ward personnel. Accompanying midwife, while being with the mother and providing continuous midwifery care, evaluating the progress of childbirth, examining the health status of the mother and fetus in order to maintain the physiological process of childbirth and avoid any unnecessary intervention by providing emotional support, training to control fear and worry and training how to control Pain helped to increase the mother's peace and comfort. The support provided to the mother during the stages of labor by the midwife are: constant presence at the mother's bedside, reassurance, establishing a close relationship, listening to the mother's concerns and words, encouraging proper breathing techniques, using massage or compresses. cold or local heat (according to the mother's desire), training to relax the body with visualization, giving simple and understandable information about the stages of childbirth, encouraging frequent emptying of the bladder, helping and encouraging mobility and changing the position, keeping the mother informed From the progress and process of childbirth by performing vaginal examinations and controlling contractions, helping the mother to be in a comfortable position, encouraging the mother to deliver early when necessary, strengthening the morale, preparing the mother for childbirth, advising the mother to cooperate with the birth attendant and Teaching the correct way to breathe and apply pressure when trying to expel the fetus, giving information about the importance of skin-to-skin contact with the baby immediately after delivery and early breastfeeding and the need for the mother's cooperation. After delivery, the mother was supported to communicate with the baby through skin-to-skin contact and early breastfeeding. Intervention 2: Intervention group: Care by trained lay companion: inThe trained (lay) companion group The mothers were asked to nominate a person of their choice to accompany them during the labor and birth. A trained person should have at least one experience of childbirth. After being selected by the mother and introduced to the research team, they were invited to participate in educational classes, during which they were taught how to care for the mothers during labor. They were also assured that they would be notified of the time of the classes. After sampling was completed in this group, two training sessions were designed and the time of these sessions was coordinated with the mothers and their companions. Since a number of samples were excluded from the study for reasons such as not attending the training sessions, same number of eligible people were randomly assigned to the study to prevent any problem in statistical analysis. The mothers of this group finally gave birth in Imam Khomeini and Taleghani hospitals, according to their choice (Sina Hospital is private and Imam Khomeini and Taleghani Hospitals are public).In the sessions, topics such as stages of labor, symptoms of labor, measures needed to facilitate labor, and role of the companion before coming to the hospital including: helping a pregnant woman to go to the hospital if she sees any signs of labor, continuous presence beside the patient, gaining the trust, building a sincere relationship, listening to the mother's concerns and worries, encouraging proper breathing techniques, using massage or applying cold or hot compresses (according to the mother's wishes), teaching relaxation methods, giving simple and understandable information about the birth process, encouraging frequent emptying of the bladder, helping and encouraging mobility, changing the position during the labor and using the delivery ball if possible, keeping the mother informed of the progress and birth process, helping the mother to get comfortable, encouraging the mother to push when needed, boosting her mood, preparing the mother for childbirth, advising the mother to work with the birth agent and teaching her how to breathe properly, applying pressure when infant is coming out, giving information about the importance of skin-to-skin contact with the baby immediately after the birth and the importance of early breastfeeding, were taught.At the last session, the mothers and their companions were asked to inform the researcher when they see signs of childbirth, so that coordination could be made with the delivery and obstetric unit of Imam Khomeini and Taleghani Hospitals to accept them. No - There is not a plan to make this available Justification or reason for not sharing IPD is because of confidentiality the participants characteristics wont be shared.
public Afsaneh Azadpour
Bahar 3 Alley, Erfan Aven, Hepco Aven, Arak
Arak Iran (Islamic Republic of) 3818835543 +98 86 3366 6593 Afsaneh.azadpour@yahoo.com Tehran University of Medical Sciences scientific Afsaneh Azadpour
Bahar 3 Alley, Erfan Aven, Hepco Aven, Arak
Arak Iran (Islamic Republic of) 3818835543 +98 86 3366 6593 Afsaneh.azadpour@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Low-risk pregnant women aged 18 to 40 years Gestational age of 38 to 42 weeks based on accurate LMP or ultrasound Spontaneous onset of labor pains Healthy, live fetus Single fetus Display of head Normal cervical delivery conditions according to midwife or physician 18 years 40 years Female Any known physical disease related or unrelated to pregnancy Mental illness of mother Known fetal abnormalities Previous history of cesarean section or desire to have selective cesarean section History of giving birth to infant who weighs less than 2500 or more than 4000 grams N/A N/A Intervention group: Care by doula: The samples of the care group were selected by accompanying midwives from private midwifery service centers. The accompanying midwife was also one of the staff of the center who personally undertakes all care services within the scope of duties of the accompanying midwife in labor, but the delivery was performed by the ward personnel. Accompanying midwife, while being with the mother and providing continuous midwifery care, evaluating the progress of childbirth, examining the health status of the mother and fetus in order to maintain the physiological process of childbirth and avoid any unnecessary intervention by providing emotional support, training to control fear and worry and training how to control Pain helped to increase the mother's peace and comfort. The support provided to the mother during the stages of labor by the midwife are: constant presence at the mother's bedside, reassurance, establishing a close relationship, listening to the mother's concerns and words, encouraging proper breathing techniques, using massage or compresses. cold or local heat (according to the mother's desire), training to relax the body with visualization, giving simple and understandable information about the stages of childbirth, encouraging frequent emptying of the bladder, helping and encouraging mobility and changing the position, keeping the mother informed From the progress and process of childbirth by performing vaginal examinations and controlling contractions, helping the mother to be in a comfortable position, encouraging the mother to deliver early when necessary, strengthening the morale, preparing the mother for childbirth, advising the mother to cooperate with the birth attendant and Teaching the correct way to breathe and apply pressure when trying to expel the fetus, giving information about the importance of skin-to-skin contact with the baby immediately after delivery and early breastfeeding and the need for the mother's cooperation. After delivery, the mother was supported to communicate with the baby through skin-to-skin contact and early breastfeeding. Intervention group: Care by trained lay companion: inThe trained (lay) companion group The mothers were asked to nominate a person of their choice to accompany them during the labor and birth. A trained person should have at least one experience of childbirth. After being selected by the mother and introduced to the research team, they were invited to participate in educational classes, during which they were taught how to care for the mothers during labor. They were also assured that they would be notified of the time of the classes. After sampling was completed in this group, two training sessions were designed and the time of these sessions was coordinated with the mothers and their companions. Since a number of samples were excluded from the study for reasons such as not attending the training sessions, same number of eligible people were randomly assigned to the study to prevent any problem in statistical analysis. The mothers of this group finally gave birth in Imam Khomeini and Taleghani hospitals, according to their choice (Sina Hospital is private and Imam Khomeini and Taleghani Hospitals are public).In the sessions, topics such as stages of labor, symptoms of labor, measures needed to facilitate labor, and role of the companion before coming to the hospital including: helping a pregnant woman to go to the hospital if she sees any signs of labor, continuous presence beside the patient, gaining the trust, building a sincere relationship, listening to the mother's concerns and worries, encouraging proper breathing techniques, using massage or applying cold or hot compresses (according to the mother's wishes), teaching relaxation methods, giving simple and understandable information about the birth process, encouraging frequent emptying of the bladder, helping and encouraging mobility, changing the position during the labor and using the delivery ball if possible, keeping the mother informed of the progress and birth process, helping the mother to get comfortable, encouraging the mother to push when needed, boosting her mood, preparing the mother for childbirth, advising the mother to work with the birth agent and teaching her how to breathe properly, applying pressure when infant is coming out, giving information about the importance of skin-to-skin contact with the baby immediately after the birth and the importance of early breastfeeding, were taught.At the last session, the mothers and their companions were asked to inform the researcher when they see signs of childbirth, so that coordination could be made with the delivery and obstetric unit of Imam Khomeini and Taleghani Hospitals to accept them Active phase duration of labor. Timepoint: Dilatation of 3-10 cm. Method of measurement: Researcher-made checklist. Second stage duration of labor. Timepoint: From 10 cm dilatation to complete exit of placenta. Method of measurement: Researcher-made checklist. Satisfaction birth. Timepoint: 24 hours after delivery. Method of measurement: Satisfaction birth questionnaire by Hollins Martin. Anxiety of mothers during labor. Timepoint: From 3 to 10 cm dilatation and then 8-10 cm. Method of measurement: The Spielberger covert and overt anxiety questionnaire. Duration of skin-to-skin contact. Timepoint: Postpartum. Method of measurement: Researcher-made checklist. Severity of pain. Timepoint: At the time of admission, the first, second, third, fourth and fifth hour after admission. Method of measurement: Visual Analogue Scale for pain. Duration of skin-to-skin contact. Timepoint: postpartum. Method of measurement: Researcher-made checklist. How to contact mother and infant. Timepoint: Postpartum. Method of measurement: Researcher-made checklist. Time to start skin-to-skin contact. Timepoint: Postpartum. Method of measurement: Researcher-made checklist. Time to start feeding. Timepoint: Postpartum. Method of measurement: Researcher-made checklist. Apgar first and fifth minutes after birth. Timepoint: Postpartum. Method of measurement: Birth information. Tehran University of Medical Sciences Approved 2018-09-01 Ethics committee of Tehran University of Medical Sciences Central Building of Tehran University of Medical Sciences, Intersection of Qods Street, Keshavarz Boulevard, Tehran Tehran Tehran Iran (Islamic Republic of)