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

Not Applicable

Completed

• Conditions: Post Operative Pain; Caesarean Section; Mother-Child Relations; Postpartum Depression
• Interventions: Procedure: Mother's push during CS

• Registration Number: NCT05520580
• Lead Sponsor: Hannover Medical School

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2020-05-01
• Primary Completion: 2021-03-20
• Study Completion: 2021-03-20
• Status Verified: 2022-08
• Study First Submitted: 2022-08-19
• Study First Submitted QC: 2022-08-25
• Last Update Submitted: 2022-08-25
• Study First Posted: 2022-08-30
• Last Update Posted: 2022-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Assisted group	Mother's push during CS	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Quantity of the Intraoperative maternal blood loss	Intraoperative - end of the operation	Quantity of blood loss that the surgeon has been estimated
Rate of birth asphyxia	Intraoperative , directly after the baby delivery	Using APGAR score , PH sampling from umbilical cord (venous and arterial)
Different in the operation duration between the two groups	At end of the operation	Using the time , that was documented in the operation protocols
Incidence of Postpartum Depression	Postoperative day 0,1,2	Using the Edinburgh Postnatal Depression Scale (EPDS)
Incidence and quality of Breastfeeding	Postoperative day 0,1,2	Using the Breastfeeding Self-Efficacy Scale, Short Form (BSES-SF)
senses of participation and control	Intraoperative, directly after the baby delivery	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 .
Intensity of intraoperative fundal pressure	Intraoperative after the delivery of the baby	Using the Likert scale

Trial Locations

Locations (1)

Hanover medical school; 🇩🇪 Hanover, Lower Saxony, Germany