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

Hannover Medical School (MHH)

Status: Completed

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

Treatments: Procedure: Mother's push during CS

Study type: Interventional

Funder types: Other

Identifiers

NCT05520580

Rklapdor

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Conventional Group

No Intervention group

Description:

Received a classic CS without intervention (Control group)

Assisted group

Experimental group

Description:

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.

Treatment:

Procedure: Mother's push during CS