Clinical trial NCT05520580: Effect of Mother's Push at Cesarean Delivery Mother's PUSHING AT CS A RANDOMIZED CONTROLLED TRIAL
Official title: Effect of Mother's Active Pushing at Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caesarean Section
Mother-Child Relations
Post Operative Pain
Postpartum Depression
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2022-08-30
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective randomized study
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in postoperative pain of the mother
timeFrame: directly after delivery (intraoperative), 4-6 hours after delivery and on the first and second postoperative days
Secondary outcomes:
measure: Incidence and quality of Breastfeeding
timeFrame: Postoperative day 0,1,2
measure: Incidence of Postpartum Depression
timeFrame: Postoperative day 0,1,2
measure: senses of participation and control
timeFrame: Intraoperative, directly after the baby delivery
measure: Different in the operation duration between the two groups
timeFrame: At end of the operation
measure: Intensity of intraoperative fundal pressure
timeFrame: Intraoperative after the delivery of the baby
measure: Quantity of the Intraoperative maternal blood loss
timeFrame: Intraoperative - end of the operation
measure: Rate of birth asphyxia
timeFrame: Intraoperative , directly after the baby delivery
Other outcomes:
Locations:
city: Hanover
country: Germany
facility: Hanover medical school
state: Lower Saxony
Study officials:
affiliation: Hannover Medical School
name: Peter Hillemanns, Professor
role: STUDY_CHAIR
affiliation: Hannover medical school (MHH)
name: Stefan Engeli, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Beckmann M W, Bader W BI. Finanzierung und finanzielle Probleme von Leistungen und Strukturen im Fachgebiet Gynäkologie und Geburtshilfe im Jahr 2011 - allgemeine Aspekte und geburtshilfliche Versorgung. Geburtsh Frauenheilk. 2011.
citation: DiMatteo MR, Morton SC, Lepper HS, Damush TM, Carney MF, Pearson M, Kahn KL. Cesarean childbirth and psychosocial outcomes: a meta-analysis. Health Psychol. 1996 Jul;15(4):303-14. doi: 10.1037//0278-6133.15.4.303.
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citation: Armbrust R, Hinkson L, von Weizsacker K, Henrich W. The Charite cesarean birth: a family orientated approach of cesarean section. J Matern Fetal Neonatal Med. 2016;29(1):163-8. doi: 10.3109/14767058.2014.991917. Epub 2015 Jan 9.
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citation: Sitter-Trollmann P. " Stillen und Selbstwirksamkeit - ein Beitrag zur präventiven Erfassung von Stillproblemen durch standardisierte Instrumente ". 2011;147. Available from: http://othes.univie.ac.at/16715/
citation: Vaziri F, Arzhe A, Asadi N, Pourahmad S, Moshfeghy Z. Spontaneous Pushing in Lateral Position versus Valsalva Maneuver During Second Stage of Labor on Maternal and Fetal Outcomes: A Randomized Clinical Trial. Iran Red Crescent Med J. 2016 Aug 10;18(10):e29279. doi: 10.5812/ircmj.29279. eCollection 2016 Oct.
citation: Siddik SM, Aouad MT, Jalbout MI, Rizk LB, Kamar GH, Baraka AS. Diclofenac and/or propacetamol for postoperative pain management after cesarean delivery in patients receiving patient controlled analgesia morphine. Reg Anesth Pain Med. 2001 Jul-Aug;26(4):310-5. doi: 10.1053/rapm.2001.21828.