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IRCT20120718010324N69 IRCT 2022-05-01 Tabriz University of Medical Sciences Comparison of the effect of implementing the WHO maternity care model with routine hospital care on the childbirth experience of women Effect of implementing the WHO maternity care model on the childbirth experience, fear of childbirth, and quality of intrapartum care: a randomized controlled clinical trial 2022-05-19 anticipated 108 Complete https://irct.ir/trial/62653 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: If women accept to participate in the study, they will be assigned to study groups at the beginning of the active phase of labor. In order to allocate the participants to the study groups, the stratified random blocking method (nulliparous and the second delivery) with the block sizes of 4 and 6 and a 1:1 allocation ratio will be used. For Allocation Concealment, the type of intervention will be written on paper and will be placed inside sequential numbered opaque envelopes, Blinding description: Due to the nature of the intervention, it is not possible to blind the researcher and the participants. In order to blind the outcome assessor, questionnaires related to the postpartum stage will be completed by the research assistant. N/A Delivery. Intervention 1: Intervention group: Intrapartum care in the intervention group will be based on the constructs of the care model of the World Health Organization. The nine dimensions of this model are as follows: 1) Respectful labor and childbirth care; All considerations of confidentiality and privacy, no physical harm or abuse, dignity and respect, lack of care, right to necessary information, informed consent, and choices/preferences during labor, delivery and postpartum. 2) Emotional support from a companion of choice; Suggested activities for the companion of choice include support for women (stay with her, calm her down, massage her, show her affection, and encourage and stimulate her), behave correctly when the woman faces fatigue, anxiety and worry, cries or screams or feels helpless, observe the regulations (wear standard clothes, avoid eating, smoking, or touching the equipment and devices), and inform the staff whenever it is necessary to leave the hospital). 3) Effective communication by the staff; Effective communication with the participants will include listening and being polite to them, quickly relieving their pain, behaving in a jovial fashion and being kind and close to them as well as involving the mother in decisions related to her in order to create a sense of control, independence, and security in them 4) Pain relief strategies; Non-pharmacological pain relief techniques, such as teaching diaphragmatic breathing with proper inhalation and exhalation, thermotherapy, position change, and massage, if the participant agrees. If necessary, pharmacological pain relief methods will be used at the discretion and under the supervision of a gynecologist involved in the project. 5) Regular monitoring of labor, documentation, auditing, and feedback; Documentation of labor and delivery events by partograms and delivery checklists, accurate and regular monitoring of delivery care during labor, childbirth, and the first two hours after delivery by the researcher. 6) Receiving oral fluids and food; Provision a list of foods or liquids that are easy to digest (drinking water, fruit juices, dates, biscuits, and cakes) to prepare. However, they will be free to consume whatever they want in small and frequent amounts.7) Maternal mobility and birth position of choice; Positions considered during the first stage of labor include sitting, walking, semi-sitting, four-legged, and lateral positions (both sides). The participants will be asked to begin with any position that is easier for them, hold each position for 10 minutes, and take a 10-minute rest between two positions. They should also repeat these five positions at 4-cm, 7-cm, and 10-cm of cervical dilatation. For each woman in the intervention group, depending on her tolerance and the duration of labor for an average of one hour, it will be recommended to walk several times. 8) A pre-established referral plan; Since the research setting includes sub-specialty hospitals, there will be no need for referral for the participants to receive higher levels of care. Nevertheless, they will be regularly monitored during labor and in the early postpartum period in order to coordinate with the gynecologist as soon as possible if necessary and make prompt decisions. 9) Continuity of care; To observe the continuity of care in this study, the researcher will visit the mother one day after delivery in the midwifery ward, on the tenth day, and on the fortieth day after delivery. Intervention 2: Control group: Care in the control group will be based on the routine hospital care. No - There is not a plan to make this available Justification or reason for not sharing IPD is Confidentiality of participants' information
public Somaiyeh Abdolalipour
Shariati
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3479 6770 sm.abdolalipour@yahoo.com Tabriz University of Medical Sciences scientific Dr Mojgan Mirghafourvand
Shariati
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3479 6770 mirghafourvandm@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Being at the beginning of the active phase of labor First or second pregnancy 15 years 49 years Female Multiple pregnancy Non-cephalic presentation Having indication for cesarean delivery including abnormal presentation, placenta previa and etc. Midwifery problems such as placenta previa, vaginal delivery after cesarean section, placenta abruption, preeclampsia Mothers with underlying problems such as cardiovascular disease, diabetes and etc. Having a mental disability and other psychological problems Death of one of close relatives during the last three months 080.0 Spontaneous vertex delivery Behavior Behavior Intervention group: Intrapartum care in the intervention group will be based on the constructs of the care model of the World Health Organization. The nine dimensions of this model are as follows: 1) Respectful labor and childbirth care; All considerations of confidentiality and privacy, no physical harm or abuse, dignity and respect, lack of care, right to necessary information, informed consent, and choices/preferences during labor, delivery and postpartum. 2) Emotional support from a companion of choice; Suggested activities for the companion of choice include support for women (stay with her, calm her down, massage her, show her affection, and encourage and stimulate her), behave correctly when the woman faces fatigue, anxiety and worry, cries or screams or feels helpless, observe the regulations (wear standard clothes, avoid eating, smoking, or touching the equipment and devices), and inform the staff whenever it is necessary to leave the hospital). 3) Effective communication by the staff; Effective communication with the participants will include listening and being polite to them, quickly relieving their pain, behaving in a jovial fashion and being kind and close to them as well as involving the mother in decisions related to her in order to create a sense of control, independence, and security in them 4) Pain relief strategies; Non-pharmacological pain relief techniques, such as teaching diaphragmatic breathing with proper inhalation and exhalation, thermotherapy, position change, and massage, if the participant agrees. If necessary, pharmacological pain relief methods will be used at the discretion and under the supervision of a gynecologist involved in the project. 5) Regular monitoring of labor, documentation, auditing, and feedback; Documentation of labor and delivery events by partograms and delivery checklists, accurate and regular monitoring of delivery care during labor, childbirth, and the first two hours after delivery by the researcher. 6) Receiving oral fluids and food; Provision a list of foods or liquids that are easy to digest (drinking water, fruit juices, dates, biscuits, and cakes) to prepare. However, they will be free to consume whatever they want in small and frequent amounts.7) Maternal mobility and birth position of choice; Positions considered during the first stage of labor include sitting, walking, semi-sitting, four-legged, and lateral positions (both sides). The participants will be asked to begin with any position that is easier for them, hold each position for 10 minutes, and take a 10-minute rest between two positions. They should also repeat these five positions at 4-cm, 7-cm, and 10-cm of cervical dilatation. For each woman in the intervention group, depending on her tolerance and the duration of labor for an average of one hour, it will be recommended to walk several times. 8) A pre-established referral plan; Since the research setting includes sub-specialty hospitals, there will be no need for referral for the participants to receive higher levels of care. Nevertheless, they will be regularly monitored during labor and in the early postpartum period in order to coordinate with the gynecologist as soon as possible if necessary and make prompt decisions. 9) Continuity of care; To observe the continuity of care in this study, the researcher will visit the mother one day after delivery in the midwifery ward, on the tenth day, and on the fortieth day after delivery. Control group: Care in the control group will be based on the routine hospital care Childbirth experience. Timepoint: 4-6 weeks after childbirth. Method of measurement: Childbirth Experience Questionnaire. Fear of childbirth. Timepoint: At the beginning of the active phase and in dilatation 7-8 cm. Method of measurement: Delivery Fear Scale. Quality of intrapartum care. Timepoint: 4-6 weeks after childbirth. Method of measurement: Pregnancy and Childbirth Questionnaire. Postpartum depression. Timepoint: 4-6 weeks after childbirth. Method of measurement: Edinburgh’s Postpartum Depression. Postpartum stress. Timepoint: 4-6 weeks after childbirth. Method of measurement: PTSD Symptom Scale 1. Duration of active phase of delivery. Timepoint: From dilatation 4 cm until full dilatation of cervix. Method of measurement: Partograph chart (minute). Duration of second stage of delivery. Timepoint: From full dilatation of cervix until birth of newborn. Method of measurement: Partograph chart (minute). Duration of Third stage of delivery. Timepoint: From birth of newborn until complete expulsion of placenta. Method of measurement: Partograph chart (minute). Frequency of vaginal delivery. Timepoint: After childbirth. Method of measurement: Childbirth checklist. Tendency to childbearing. Timepoint: 4-6 weeks after childbirth. Method of measurement: Tendency for childbearing checklist. Tabriz University of Medical Sciences Approved 2022-04-20 Tabriz University of Medical Sciences Ethics Committee Tabriz-Golgasht street-Tabriz University of Medical Sciences-Building 2 - Floor 3 Tabriz East Azarbaijan Iran (Islamic Republic of)