Effect of Mother's Push at Cesarean Delivery Mother's PUSHING AT CS A RANDOMIZED CONTROLLED TRIAL

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and efficacy of the mother's active pushing during cesarean delivery.

Detailed Description
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Patients, who are getting a scheduled cesarean section and having no contraindication for valsalva manoeuvres are eligible for this study. The gestational week should be between 37 and 42 weeks. Patients have to provide informed consent to this study. Patients must have epidural anaesthesia. They must understand the German language in order to understand information during cesarean section and correctly fill-out the questionnaires. Emergent cesarean sections or pregnant women known with chronic pain, severe preeclampsia or HELLP-Syndrome will be excluded. 179 patients were initially recruited, of which 79 were excluded. The 100 patients were grouped into two study groups; Conventional and Assisted Groups. The grouping was performed randomly using simple randomization. Based on the findings of Armbrust et al and our clinical experience we expect a therapeutic effect of 20% which results in a mean visual analog scale reduction of 1.2. Applying a two-sided T-Test for independent samples at a significance level of 0.05, a mean difference of 0.8 between the groups and a standard deviation of 2, we need 17 patients per treatment arm to detect a difference between both treatment groups with a power of 80%14. The number of patients per treatment arm was increased to 50 patients to make up for any missing data.

Official Title
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Effect of Mother's Active Pushing at Cesarean Delivery

Conditions
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Caesarean Section, Mother-Child Relations, Post Operative Pain, Postpartum Depression

Intervention / Treatment
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* Procedure: Mother's push during CS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Minimum age of 18 years Written consent Pregnant women between 37 - 42 weeks No fetal abnormalities. Scheduled primary C-Section (category 3&4 NICE guidelines) with epidural anaesthesia Exclusion Criteria: Emergent cesarean section Contraindication for epidural anaesthesia. Multiple pregnancies Scheduled C-section with placenta previa, accreta, increta or percreta. Secondary C-section Contraindication for Valsalva manoeuvre Known psychiatric illnesses Known chronic Pain, taking Pain killers regularly language barrier

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective randomized study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Conventional Group<br>Received a classic CS without intervention (Control group) | |
| Experimental: Assisted group<br>after uterotomy during CS, the mother was instructed and motivated to push for the delivery of the head and the shoulders of the baby. Simultaneously, the surgical assistant applied fundal pressure to support the mothers pushing if necessary. | Procedure: Mother's push during CS<br>* after uterotomy, the mother was instructed and motivated to push for the delivery of the head and the shoulders of the baby. Simultaneously, the surgical assistant applied fundal pressure to support the mothers pushing if necessary<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in postoperative pain of the mother | Discomfort and pain of the mother were assessed, on a 10-point Likert scale | directly after delivery (intraoperative), 4-6 hours after delivery and on the first and second postoperative days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and quality of Breastfeeding | Using the Breastfeeding Self-Efficacy Scale, Short Form (BSES-SF) | Postoperative day 0,1,2 | 
| Incidence of Postpartum Depression | Using the Edinburgh Postnatal Depression Scale (EPDS) | Postoperative day 0,1,2 | 
| senses of participation and control | Using likert scale. To determine the effect of the mother's push on the sense of control and participation. Studies showed that poor communications as well as fears of missing out on the birth are one of the main causes of distress during CS . Improving sense of control and participation will improve the birth experience . | Intraoperative, directly after the baby delivery | 
| Different in the operation duration between the two groups | Using the time , that was documented in the operation protocols | At end of the operation | 
| Intensity of intraoperative fundal pressure | Using the Likert scale | Intraoperative after the delivery of the baby | 
| Quantity of the Intraoperative maternal blood loss | Quantity of blood loss that the surgeon has been estimated | Intraoperative - end of the operation | 
| Rate of birth asphyxia | Using APGAR score , PH sampling from umbilical cord (venous and arterial) | Intraoperative , directly after the baby delivery |