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

Post Operative Pain Clinical Trial

Official title:

Effect of Mother's Active Pushing at Cesarean Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05520580
• Other study ID #: Rklapdor
• Status: Completed
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: March 20, 2021

Study information

• Verified date: August 2022
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 20, 2021
• Est. primary completion date: March 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Caesarean Section
• Depression, Postpartum
• Mother-Child Relations
• Pain, Postoperative
• Post Operative Pain
• Postpartum Depression

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Germany	Hanover medical school	Hanover	Lower Saxony

Sponsors (1)

Lead Sponsor	Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany, 

References & Publications (12)

Armbrust R, Hinkson L, von Weizsäcker K, Henrich W. The Charité 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. — View 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.

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. German. — View Citation

Clement S. Psychological aspects of caesarean section. Best Pract Res Clin Obstet Gynaecol. 2001 Feb;15(1):109-26. Review. — View Citation

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. — View 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. — View Citation

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. — View 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. — View 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/

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. — View 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. — View Citation

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

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence and quality of Breastfeeding	Using the Breastfeeding Self-Efficacy Scale, Short Form (BSES-SF)	Postoperative day 0,1,2
Secondary	Incidence of Postpartum Depression	Using the Edinburgh Postnatal Depression Scale (EPDS)	Postoperative day 0,1,2
Secondary	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 .	Intraoperative, directly after the baby delivery
Secondary	Different in the operation duration between the two groups	Using the time , that was documented in the operation protocols	At end of the operation
Secondary	Intensity of intraoperative fundal pressure	Using the Likert scale	Intraoperative after the delivery of the baby
Secondary	Quantity of the Intraoperative maternal blood loss	Quantity of blood loss that the surgeon has been estimated	Intraoperative - end of the operation
Secondary	Rate of birth asphyxia	Using APGAR score , PH sampling from umbilical cord (venous and arterial)	Intraoperative , directly after the baby delivery