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Completed

NCT Number: NCT04086277

Continuous Intrapartum Support to Reduce Primary Cesarean

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

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Key information

Conditions

Cesarean Section Complications

Age range

14 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

IMSS Hospital General de Zona 4

Celaya, Guanajuato, 38060, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. 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 outcomes

  1. 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)

  2. 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

  3. 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)

  4. Induction of labour

    Time frame: start of active phase (up to 1 hour)

    If oxytocin was used to induce labour. (Yes/No).

Sponsors and collaborators

Lead sponsor

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

Other Gov

Collaborators

  • Fondo de Investigación en Salud (FIS), México

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Sep 11, 2019
Registry last updated
Sep 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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