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

Post Operative Pain Clinical Trial

Official title:
Effect of Mother's Active Pushing at Cesarean Delivery

Clinical Trial Summary

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

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05520580
Study type Interventional
Source Hannover Medical School
Contact
Status Completed
Phase N/A
Start date May 1, 2020
Completion date March 20, 2021
View Details
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