NCT05520580

Brief Summary

The purpose of this study is to assess the safety and efficacy of the mother's active pushing during cesarean delivery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2021

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 30, 2022

Completed
Last Updated

August 30, 2022

Status Verified

August 1, 2022

Enrollment Period

11 months

First QC Date

August 19, 2022

Last Update Submit

August 25, 2022

Conditions

Caesarean SectionMother-Child RelationsPost Operative PainPostpartum Depression

Outcome Measures

Primary Outcomes (1)

  • Change in postoperative pain of the mother

    Discomfort and pain of the mother were assessed, on a 10-point Likert scale

    directly after delivery (intraoperative), 4-6 hours after delivery and on the first and second postoperative days

Secondary Outcomes (7)

  • Incidence and quality of Breastfeeding

    Postoperative day 0,1,2

  • Incidence of Postpartum Depression

    Postoperative day 0,1,2

  • senses of participation and control

    Intraoperative, directly after the baby delivery

  • Different in the operation duration between the two groups

    At end of the operation

  • Intensity of intraoperative fundal pressure

    Intraoperative after the delivery of the baby

  • +2 more secondary outcomes

Study Arms (2)

Conventional Group

NO INTERVENTION

Received a classic CS without intervention (Control group)

Assisted group

EXPERIMENTAL

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.

Procedure: Mother's push during CS

Interventions

Mother's push during CSPROCEDURE

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

Assisted group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanover medical school

Hanover, Lower Saxony, 30625, Germany

Location

Related Publications (13)

  • Wacker J. Geburtshilfe. Kaiserschnitt vs. Natürliche Geburt. Geburtshilfe Frauenheilkd. 2010;70(10):840-3.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 8818678BACKGROUND

  • 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.

    PMID: 11359318BACKGROUND

  • 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.

    PMID: 18651885BACKGROUND

  • 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.

    PMID: 25572878BACKGROUND

  • 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.

    PMID: 21856077BACKGROUND

  • 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.

    PMID: 9472218BACKGROUND

  • 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.

    PMID: 14649593BACKGROUND

  • 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/

    BACKGROUND

  • 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.

    PMID: 28180019BACKGROUND

  • 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.

    PMID: 11464348BACKGROUND

  • 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.

    PMID: 39601809DERIVED

MeSH Terms

Conditions

Pain, PostoperativeDepression, Postpartum

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPuerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Study Officials

  • Peter Hillemanns, Professor

    Hannover Medical School

    STUDY CHAIR

  • Stefan Engeli, Prof.

    Hannover medical school (MHH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: prospective randomized study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2022

First Posted

August 30, 2022

Study Start

May 1, 2020

Primary Completion

March 20, 2021

Study Completion

March 20, 2021

Last Updated

August 30, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)