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Continuous Intrapartum Support to Reduce Primary Cesarean

Continuous Intrapartum Support to Reduce Primary Cesarean

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04086277
Enrollment
115
Registered
2019-09-11
Start date
2018-10-01
Completion date
2018-12-31
Last updated
2019-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section Complications

Keywords

cesarean section, Continuous intrapartum support, nulliparous

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

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

PROCEDUREContinuous 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.

Sponsors

Fondo de Investigación en Salud (FIS), México
CollaboratorUNKNOWN
IMSS Hospital General de Zona 4, Celaya, Guanajauto, Mexico
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
FEMALE
Age
14 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Cesarean delivery rateUntil the occurrence of delivery (expected range from 6 hours to 12 hours)Percentage de cesarean section in the arms

Secondary

MeasureTime frameDescription
Time of labourFrom 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 scoreAt 1 and 5 minutes after deliveryIs a quick test performed on a baby at 1 and 5 minutes after birth
Obstetric analgesiaFrom 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 labourstart of active phase (up to 1 hour)If oxytocin was used to induce labour. (Yes/No).

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026