Continuous Intrapartum Support to Reduce Primary Cesarean

September 10, 2019 updated by: Luz Maria Cardona Torres, IMSS Hospital General de Zona 4, Celaya, Guanajauto, Mexico
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

115

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Guanajuato
      • Celaya, Guanajuato, Mexico, 38060
        • IMSS Hospital General de Zona 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
No Intervention: Women in labor without continuous intrapartum support.
The no intervention group received the usual obstetric care, without continuous intrapartum support.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Until the occurrence of delivery (expected range from 6 hours to 12 hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
From the active phase up to delivery (expected range from 6 hours to 12 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
At 1 and 5 minutes after delivery
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)
From the active phase up to delivery (expected range from 6 hours to 12 hours)
Induction of labour
Time Frame: start of active phase (up to 1 hour)
If oxytocin was used to induce labour. (Yes/No).
start of active phase (up to 1 hour)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Fondo de Investigación en Salud (FIS), México

Investigators

  • Principal Investigator: Luz M Cardona, Master, IMSS Hospital General de Zona 4, Celaya, Guanajauto, México

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

September 6, 2019

First Submitted That Met QC Criteria

September 10, 2019

First Posted (Actual)

September 11, 2019

Study Record Updates

Last Update Posted (Actual)

September 11, 2019

Last Update Submitted That Met QC Criteria

September 10, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • LMCT-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Through a public web address

IPD Sharing Time Frame

Since its publication, minimum 5 years.

IPD Sharing Access Criteria

web address

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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