ClinicalTrials.gg
CompletedNCT04086277Updated Sep 11, 2019

Continuous Intrapartum Support to Reduce Primary Cesarean

An interventional study of Continuous Intrapartum Support in Cesarean Section Complications, sponsored by IMSS Hospital General de Zona 4, Celaya, Guanajauto, Mexico. Completed at 1 site in Mexico. Open to female participants aged 14 Years to 40 Years. Per ClinicalTrials.gov, last updated 2019-09-11.

Sponsored by IMSS Hospital General de Zona 4, Celaya, Guanajauto, Mexico · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Oct 2018, registered Sep 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
115
Allocation
Non-randomized
Ages
14 Years to 40 Years
Sex
Female
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Study 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

Read the 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.

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Conditions studied

  • Cesarean Section Complications

Keywords

  • cesarean section
  • Continuous intrapartum support
  • nulliparous
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In context

Lead sponsor

This is the only study on the registry with IMSS Hospital General de Zona 4, Celaya, Guanajauto, Mexico as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
115 participants (actual)

Study arms

  • 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

  • No intervention
    Women in labor without continuous intrapartum support.

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

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What researchers measure

Primary outcomes

  1. Cesarean delivery rate

    Percentage de cesarean section in the arms

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

Secondary outcomes

  1. Time of labour

    Labour covered the period of time from the active phase to birth. (Hours)

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

  2. Apgar score

    Is a quick test performed on a baby at 1 and 5 minutes after birth

    Time frame: At 1 and 5 minutes after delivery

  3. Obstetric analgesia

    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)

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

  4. Induction of labour

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

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

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Study locations

1 site
  • IMSS Hospital General de Zona 4
    Celaya, Guanajuato 38060, Mexico
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References and documents

Publications

  • 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(7):CD003766. doi: 10.1002/14651858.CD003766.pub6. PubMed 28681500 ↗
  • 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. PubMed 28854903 ↗
  • 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. PubMed 18507579 ↗
  • 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. PubMed 20152972 ↗
  • 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. PubMed 19128863 ↗
  • 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. PubMed 30522458 ↗

Individual participant data

Plan to share: Yes — Through a public web address

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: Since its publication, minimum 5 years.

Access criteria: web address

Data sharing details ↗ · i0000.clarodrive.com

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2018 to primary completion in Dec 2018, 2 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 6, 2019
First posted
Sep 11, 2019
StartActual
Oct 1, 2018
Primary completionActual
Dec 31, 2018
CompletionActual
Dec 31, 2018
Last update
Sep 11, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 11, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04086277
Lead sponsor
IMSS Hospital General de Zona 4, Celaya, Guanajauto, Mexico
Collaborators
Fondo de Investigación en Salud (FIS), México
Responsible party
Luz Maria Cardona Torres (Subjefe de Educación e Investigación en Salud, IMSS Hospital General de Zona 4, Celaya, Guanajauto, Mexico) — Principal investigator
First posted
Sep 11, 2019
Start date
Oct 1, 2018
Primary completion
Dec 31, 2018
Completion
Dec 31, 2018
Last update
Sep 11, 2019

Study contacts

Luz M Cardona, Master
principal investigator · IMSS Hospital General de Zona 4, Celaya, Guanajauto, México

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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