Continuous Intrapartum Support to Reduce Primary Cesarean

NCT04086277 | Completed DMC

• 1 other identifier: LMCT-02
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study was to evaluate the intervention of intrapartum continuous support by a professional nurse with a university degree to reduce the nulliparous, term, singleton, vertex (NTSV) cesarean birth rate, in women pregnant less than 40 years in the HGZ No. 4 of the Guanajuato delegation of the Mexican Institute of Social Security, Mexico

Conditions

Cesarean Section Complications

Keywords

cesarean section; Continuous intrapartum support; nulliparous

Outcome Measures

Primary Outcomes (1)

• Cesarean delivery rate

  Percentage de cesarean section in the arms

  Until the occurrence of delivery (expected range from 6 hours to 12 hours)

Secondary Outcomes (4)

• Time of labour

  From the active phase up to delivery (expected range from 6 hours to 12 hours)

• Apgar score

  At 1 and 5 minutes after delivery

• Obstetric analgesia

  From the active phase up to delivery (expected range from 6 hours to 12 hours)

• Induction of labour

  start of active phase (up to 1 hour)

Study Arms (2)

Women in labor with continuous intrapartum support

EXPERIMENTAL

Continuous intrapartum support was based on three basic aspects: 1) emotional support, 2) physical support and comfort measures and 3) information and advice.

Procedure: Continuous Intrapartum Support

Women in labor without continuous intrapartum support.

NO INTERVENTION

The no intervention group received the usual obstetric care, without continuous intrapartum support.

Interventions

Continuous Intrapartum Support PROCEDURE

Received the usual obstetric care plus continuous intrapartum support that was provided by a Bachelor of Nursing and Obstetrics who received prior training by a professional doula.

Women in labor with continuous intrapartum support

Eligibility Criteria

• Age: 14 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Women pregnant
• Nulliparous
• Term pregnancy
• Singleton pregnancy
• Vertex position

You may not qualify if:

• Patients with maternal, fetal, or mixed cesarean indications were excluded.

Sponsors & Collaborators

• IMSS Hospital General de Zona 4, Celaya, Guanajauto, Mexico: lead
• Fondo de Investigación en Salud (FIS), México: collaborator

Study Sites (1)

IMSS Hospital General de Zona 4

Celaya, Guanajuato, 38060, Mexico

Location

Related Publications (7)

• World Health Organization and Human Reproduction Programme. WHO Statement on Caesarean Section Rates. Statement. Geneva, Switzerland: World Health Organization, Department of Reproductive Health and Research ; 2015.

  BACKGROUND

• Bohren MA, Hofmeyr GJ, Sakala C, Fukuzawa RK, Cuthbert A. Continuous support for women during childbirth. Cochrane Database Syst Rev. 2017 Jul 6;7(7):CD003766. doi: 10.1002/14651858.CD003766.pub6.

  PMID: 28681500 BACKGROUND

• Kabakian-Khasholian T, Portela A. Companion of choice at birth: factors affecting implementation. BMC Pregnancy Childbirth. 2017 Aug 31;17(1):265. doi: 10.1186/s12884-017-1447-9.

  PMID: 28854903 BACKGROUND

• McGrath SK, Kennell JH. A randomized controlled trial of continuous labor support for middle-class couples: effect on cesarean delivery rates. Birth. 2008 Jun;35(2):92-7. doi: 10.1111/j.1523-536X.2008.00221.x.

  PMID: 18507579 BACKGROUND

• Kashanian M, Javadi F, Haghighi MM. Effect of continuous support during labor on duration of labor and rate of cesarean delivery. Int J Gynaecol Obstet. 2010 Jun;109(3):198-200. doi: 10.1016/j.ijgo.2009.11.028. Epub 2010 Feb 12.

  PMID: 20152972 BACKGROUND

• Khresheh R. Support in the first stage of labour from a female relative: the first step in improving the quality of maternity services. Midwifery. 2010 Dec;26(6):e21-4. doi: 10.1016/j.midw.2008.11.003. Epub 2009 Jan 6.

  PMID: 19128863 BACKGROUND

• Wang M, Song Q, Xu J, Hu Z, Gong Y, Lee AC, Chen Q. Continuous support during labour in childbirth: a Cross-Sectional study in a university teaching hospital in Shanghai, China. BMC Pregnancy Childbirth. 2018 Dec 6;18(1):480. doi: 10.1186/s12884-018-2119-0.

  PMID: 30522458 BACKGROUND

Study Officials

• Luz M Cardona, Master

  IMSS Hospital General de Zona 4, Celaya, Guanajauto, México

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Subjefe de Educación e Investigación en Salud

Model Details: The control group was composed of women with labour, who attended the General Hospital of Zone 4 of the Guanajuato Delegation of the IMSS in the period of October-December 2016. The study group was composed of women with labour who presented at the same hospital to receive obstetric care in the period of October - December 2018.

Study Record Dates

• First Submitted: September 6, 2019
• First Posted: September 11, 2019
• Study Start: October 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: September 11, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Since its publication, minimum 5 years.
• Access Criteria: web address

Locations

ME (1)