Effect of Mother's Active Pushing at Cesarean Delivery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hannover Medical School
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Change in postoperative pain of the mother
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Conventional Group
Received a classic CS without intervention (Control group)
Assisted group
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.
Intervention: Mother's push during CS (Procedure)
Outcomes
Primary Outcomes
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
- Quantity of the Intraoperative maternal blood loss(Intraoperative - end of the operation)
- Rate of birth asphyxia(Intraoperative , directly after the baby delivery)
- Different in the operation duration between the two groups(At end of the operation)
- Incidence of Postpartum Depression(Postoperative day 0,1,2)
- Incidence and quality of Breastfeeding(Postoperative day 0,1,2)
- senses of participation and control(Intraoperative, directly after the baby delivery)
- Intensity of intraoperative fundal pressure(Intraoperative after the delivery of the baby)