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Completed

NCT Number: NCT05520580

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mother's push during CS

Procedure

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

Primary outcomes

  1. Change in postoperative pain of the mother

    Time frame: 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 outcomes

  1. Incidence and quality of Breastfeeding

    Time frame: Postoperative day 0,1,2

    Using the Breastfeeding Self-Efficacy Scale, Short Form (BSES-SF)

  2. Incidence of Postpartum Depression

    Time frame: Postoperative day 0,1,2

    Using the Edinburgh Postnatal Depression Scale (EPDS)

  3. senses of participation and control

    Time frame: 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 .

  4. Different in the operation duration between the two groups

    Time frame: At end of the operation

    Using the time , that was documented in the operation protocols

  5. Intensity of intraoperative fundal pressure

    Time frame: Intraoperative after the delivery of the baby

    Using the Likert scale

  6. Quantity of the Intraoperative maternal blood loss

    Time frame: Intraoperative - end of the operation

    Quantity of blood loss that the surgeon has been estimated

  7. Rate of birth asphyxia

    Time frame: Intraoperative , directly after the baby delivery

    Using APGAR score , PH sampling from umbilical cord (venous and arterial)

Sponsors and collaborators

Lead sponsor

Hannover Medical School

Other

Registry information

Official study title

Effect of Mother's Active Pushing at Cesarean Delivery

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 30, 2022
Registry last updated
Aug 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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