Hanover medical school
Hanover, Lower Saxony, 30625, Germany
NCT Number: NCT05520580
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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Notify Me18 year and older
Female
Interventional
Not applicable
Hanover, Lower Saxony, 30625, Germany
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
Time frame: Postoperative day 0,1,2
Using the Breastfeeding Self-Efficacy Scale, Short Form (BSES-SF)
Time frame: Postoperative day 0,1,2
Using the Edinburgh Postnatal Depression Scale (EPDS)
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 .
Time frame: At end of the operation
Using the time , that was documented in the operation protocols
Time frame: Intraoperative after the delivery of the baby
Using the Likert scale
Time frame: Intraoperative - end of the operation
Quantity of blood loss that the surgeon has been estimated
Time frame: Intraoperative , directly after the baby delivery
Using APGAR score , PH sampling from umbilical cord (venous and arterial)
Hannover Medical School
Other
Effect of Mother's Active Pushing at Cesarean Delivery
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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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