Caesarean Section, Mother-Child Relations, Post Operative Pain, Postpartum Depression
Conditions
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.
Interventions
PROCEDUREMother's push during CS
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
Sponsors
Hannover Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)
Intervention model description
prospective randomized study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Postpartum Depression | Postoperative day 0,1,2 | Using the Edinburgh Postnatal Depression Scale (EPDS) |
| 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 . |
| 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 and quality of Breastfeeding | Postoperative day 0,1,2 | Using the Breastfeeding Self-Efficacy Scale, Short Form (BSES-SF) |
| 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) |
| Intensity of intraoperative fundal pressure | Intraoperative after the delivery of the baby | Using the Likert scale |
Countries
Germany
Outcome results
None listed