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

Primary Purpose

Caesarean Section, Mother-Child Relations, Post Operative Pain

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Mother's push during CS
Sponsored by
Hannover Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Caesarean Section

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Hanover medical school

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Conventional Group

Assisted group

Arm Description

Received a classic CS without intervention (Control 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence and quality of Breastfeeding
Using the Breastfeeding Self-Efficacy Scale, Short Form (BSES-SF)
Incidence of Postpartum Depression
Using the Edinburgh Postnatal Depression Scale (EPDS)
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 .
Different in the operation duration between the two groups
Using the time , that was documented in the operation protocols
Intensity of intraoperative fundal pressure
Using the Likert scale
Quantity of the Intraoperative maternal blood loss
Quantity of blood loss that the surgeon has been estimated
Rate of birth asphyxia
Using APGAR score , PH sampling from umbilical cord (venous and arterial)

Full Information

First Posted
August 19, 2022
Last Updated
August 25, 2022
Sponsor
Hannover Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT05520580
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
March 20, 2021 (Actual)
Study Completion Date
March 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hannover Medical School

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caesarean Section, Mother-Child Relations, Post Operative Pain, Postpartum Depression

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective randomized study
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional Group
Arm Type
No Intervention
Arm Description
Received a classic CS without intervention (Control group)
Arm Title
Assisted group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Mother's push during CS
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in postoperative pain of the mother
Description
Discomfort and pain of the mother were assessed, on a 10-point Likert scale
Time Frame
directly after delivery (intraoperative), 4-6 hours after delivery and on the first and second postoperative days
Secondary Outcome Measure Information:
Title
Incidence and quality of Breastfeeding
Description
Using the Breastfeeding Self-Efficacy Scale, Short Form (BSES-SF)
Time Frame
Postoperative day 0,1,2
Title
Incidence of Postpartum Depression
Description
Using the Edinburgh Postnatal Depression Scale (EPDS)
Time Frame
Postoperative day 0,1,2
Title
senses of participation and control
Description
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
Intraoperative, directly after the baby delivery
Title
Different in the operation duration between the two groups
Description
Using the time , that was documented in the operation protocols
Time Frame
At end of the operation
Title
Intensity of intraoperative fundal pressure
Description
Using the Likert scale
Time Frame
Intraoperative after the delivery of the baby
Title
Quantity of the Intraoperative maternal blood loss
Description
Quantity of blood loss that the surgeon has been estimated
Time Frame
Intraoperative - end of the operation
Title
Rate of birth asphyxia
Description
Using APGAR score , PH sampling from umbilical cord (venous and arterial)
Time Frame
Intraoperative , directly after the baby delivery

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Hillemanns, Professor
Organizational Affiliation
Hannover Medical School
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Stefan Engeli, Prof.
Organizational Affiliation
Hannover medical school (MHH)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hanover medical school
City
Hanover
State/Province
Lower Saxony
ZIP/Postal Code
30625
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Results Reference
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PubMed Identifier
8818678
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
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PubMed Identifier
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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.
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Effect of Mother's Push at Cesarean Delivery Mother's PUSHING AT CS A RANDOMIZED CONTROLLED TRIAL

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