Continuous Intrapartum Support to Reduce Primary Cesarean

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2018

Detailed Description

Continuous intrapartum support is a strategy used to decrease the cesarean section rate, where multiple factors influence its effectiveness (start and duration of support, professional training of support staff, and others.). The objective of the study was to decrease the rate of deliveries by cesarean, through continuous intrapartum support during the active phase until birth, by a professional nurse with a university degree, the support was based on three basic aspects: 1) emotional support, 2) physical support and comfort measures and 3) information and counseling, for which a quasi-experimental study was conducted, with a study population of 115 women in labour (nulliparous, full-term, single product, vertex position) and under 40 years, a group control was formed (n = 55) who received routine maternal care and a study group (n = 60) who received continuous intrapartum support.

Interventions

  • Procedure: Continuous Intrapartum Support
    • 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.

Arms, Groups and Cohorts

  • Experimental: Women in labor with continuous intrapartum support
    • Continuous intrapartum support was based on three basic aspects: 1) emotional support, 2) physical support and comfort measures and 3) information and advice.
  • No Intervention: Women in labor without continuous intrapartum support.
    • The no intervention group received the usual obstetric care, without continuous intrapartum support.

Clinical Trial Outcome Measures

Primary Measures

  • Cesarean delivery rate
    • Time Frame: Until the occurrence of delivery (expected range from 6 hours to 12 hours)
    • Percentage de cesarean section in the arms

Secondary Measures

  • Time of labour
    • Time Frame: From the active phase up to delivery (expected range from 6 hours to 12 hours)
    • Labour covered the period of time from the active phase to birth. (Hours)
  • Apgar score
    • Time Frame: At 1 and 5 minutes after delivery
    • Is a quick test performed on a baby at 1 and 5 minutes after birth
  • Obstetric analgesia
    • Time Frame: From the active phase up to delivery (expected range from 6 hours to 12 hours)
    • If obstetric analgesia was applied to reduce the pain of labour. (Yes/No) If obstetric analgesia was applied to reduce the pain of labour. (Yes/No)
  • Induction of labour
    • Time Frame: start of active phase (up to 1 hour)
    • If oxytocin was used to induce labour. (Yes/No).

Participating in This Clinical Trial

Inclusion Criteria

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

Exclusion Criteria

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

Gender Eligibility: Female

Minimum Age: 14 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • IMSS Hospital General de Zona 4, Celaya, Guanajauto, Mexico
  • Collaborator
    • Fondo de Investigación en Salud (FIS), México
  • Provider of Information About this Clinical Study
    • Principal Investigator: Luz Maria Cardona Torres, Subjefe de Educación e Investigación en Salud – IMSS Hospital General de Zona 4, Celaya, Guanajauto, Mexico
  • Overall Official(s)
    • Luz M Cardona, Master, Principal Investigator, IMSS Hospital General de Zona 4, Celaya, Guanajauto, México

References

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.

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

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. Review.

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.

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.

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.

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.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.