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Caesarean SectionNCT05520580

Effect of Mother's Push at Cesarean Delivery Mother's PUSHING AT CS A RANDOMIZED CONTROLLED TRIAL

A study testing Mother's push during CS in people with Caesarean Section and Mother-Child Relations, run by Hannover Medical School at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
What is being tested?
Mother's push during CS
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteGermany
Study dates
1 May 2020to 20 Mar 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Hanover medical school

    Hanover, Lower Saxony, 30625

Other trials in Germany

About this study

Official title: Effect of Mother's Active Pushing at Cesarean Delivery

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

Read the 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.

Being tested
Mother's push during CS
Medical subject headings
Pain, Postoperative, Depression, Postpartum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mother's push during CSProcedure or surgery

    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

Study groups in NCT05520580
Study groupRoleWhat they receive
Conventional GroupNo interventionReceived a classic CS without intervention (Control group)
Assisted groupExperimentalafter 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.
Receives: Procedure: Mother's push during CS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in postoperative pain of the mother

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

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

Secondary outcomes (7)

  1. Incidence and quality of Breastfeeding

    Using the Breastfeeding Self-Efficacy Scale, Short Form (BSES-SF)

    Measured: Postoperative day 0,1,2

  2. Incidence of Postpartum Depression

    Using the Edinburgh Postnatal Depression Scale (EPDS)

    Measured: Postoperative day 0,1,2

  3. senses of participation and control

    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 .

    Measured: Intraoperative, directly after the baby delivery

  4. Different in the operation duration between the two groups

    Using the time , that was documented in the operation protocols

    Measured: At end of the operation

  5. Intensity of intraoperative fundal pressure

    Using the Likert scale

    Measured: Intraoperative after the delivery of the baby

  6. Quantity of the Intraoperative maternal blood loss

    Quantity of blood loss that the surgeon has been estimated

    Measured: Intraoperative - end of the operation

  7. Rate of birth asphyxia

    Using APGAR score , PH sampling from umbilical cord (venous and arterial)

    Measured: Intraoperative , directly after the baby delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2022
  2. Study start1 May 2020
  3. Primary completion20 Mar 2021
  4. Study completion20 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Model description
prospective randomized study
Masking
Single blind
Who is masked
Participant
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05520580
Sponsor's protocol ID
Rklapdor
Status last verified
Aug 2022
First submitted
19 Aug 2022
Last updated
30 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 8818678

  • 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.

    PubMed 11359318

  • 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.

    PubMed 18651885

  • 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.

    PubMed 25572878

  • 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.

    PubMed 21856077

  • 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.

    PubMed 9472218

  • 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.

    PubMed 14649593

  • 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.

    PubMed 28180019

  • 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.

    PubMed 11464348

  • 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.

    PubMed 39601809

Questions about this trial

What is this clinical trial studying?

A study testing Mother's push during CS in people with Caesarean Section and Mother-Child Relations, run by Hannover Medical School at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in postoperative pain of the mother (time frame: directly after delivery (intraoperative), 4-6 hours after delivery and on the first and second postoperative days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05520580, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2022.

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