Effect of Mother's Push at Cesarean Delivery Mother's PUSHING AT CS A RANDOMIZED CONTROLLED TRIAL
NCT ID: NCT05520580
Last Updated: 2022-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2020-05-01
2021-03-20
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
SINGLE
Study Groups
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Conventional Group
Received a classic CS without intervention (Control group)
No interventions assigned to this 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.
Mother'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
Interventions
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Mother'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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
Yes
Sponsors
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Hannover Medical School
OTHER
Responsible Party
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Principal Investigators
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Peter Hillemanns, Professor
Role: STUDY_CHAIR
Hannover Medical School
Stefan Engeli, Prof.
Role: PRINCIPAL_INVESTIGATOR
Hannover medical school (MHH)
Locations
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Hanover medical school
Hanover, Lower Saxony, Germany
Countries
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References
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Wacker J. Geburtshilfe. Kaiserschnitt vs. Natürliche Geburt. Geburtshilfe Frauenheilkd. 2010;70(10):840-3.
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.
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.
Clement S. Psychological aspects of caesarean section. Best Pract Res Clin Obstet Gynaecol. 2001 Feb;15(1):109-26. doi: 10.1053/beog.2000.0152.
Smith J, Plaat F, Fisk NM. The natural caesarean: a woman-centred technique. BJOG. 2008 Jul;115(8):1037-42; discussion 1042. doi: 10.1111/j.1471-0528.2008.01777.x.
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.
Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-2404. doi: 10.1016/j.pain.2011.07.005.
Bergant AM, Nguyen T, Heim K, Ulmer H, Dapunt O. [German language version and validation of the Edinburgh postnatal depression scale]. Dtsch Med Wochenschr. 1998 Jan 16;123(3):35-40. doi: 10.1055/s-2007-1023895. German.
Dennis CL. The breastfeeding self-efficacy scale: psychometric assessment of the short form. J Obstet Gynecol Neonatal Nurs. 2003 Nov-Dec;32(6):734-44. doi: 10.1177/0884217503258459.
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/
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.
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.
Sayed A, Sayed AA, Fard D, Hillemanns P, Von Kaisenberg C, Klapdor R. Effect of mother's active pushing at cesarean delivery: a randomized controlled trial. Arch Gynecol Obstet. 2025 Mar;311(3):599-607. doi: 10.1007/s00404-024-07835-1. Epub 2024 Nov 27.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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Rklapdor
Identifier Type: -
Identifier Source: org_study_id
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