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Cesarean Section ComplicationsNCT04086277

Continuous Intrapartum Support to Reduce Primary Cesarean

A study testing Continuous Intrapartum Support in people with Cesarean Section Complications, run by IMSS Hospital General de Zona 4, Celaya, Guanajauto, Mexico at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 14 to 40 years, women only
Conditions the study is for
Cesarean Section Complications
What is being tested?
Continuous Intrapartum Support
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
115 participants
Where
1 siteMexico
Study dates
1 Oct 2018to 31 Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 40 years
  • Women only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • IMSS Hospital General de Zona 4

    Celaya, Guanajuato, 38060

Other trials in Mexico

About this study

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.

Being tested
Continuous Intrapartum Support
Keywords
cesarean section, Continuous intrapartum support, nulliparous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Continuous Intrapartum SupportProcedure or surgery

    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.

Study groups in NCT04086277
Study groupRoleWhat they receive
Women in labor with continuous intrapartum supportExperimentalContinuous intrapartum support was based on three basic aspects: 1) emotional support, 2) physical support and comfort measures and 3) information and advice.
Receives: Procedure: Continuous Intrapartum Support
Women in labor without continuous intrapartum support.No interventionThe no intervention group received the usual obstetric care, without continuous intrapartum support.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cesarean delivery rate

    Percentage de cesarean section in the arms

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

Secondary outcomes (4)

  1. Time of labour

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

    Measured: 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

    Measured: 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)

    Measured: 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).

    Measured: start of active phase (up to 1 hour)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2019
  2. Study start1 Oct 2018
  3. Primary completion31 Dec 2018
  4. Study completion31 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
115 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04086277
Sponsor's protocol ID
LMCT-02
Status last verified
Sep 2019
First submitted
6 Sep 2019
Last updated
11 Sep 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Through a public web address

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

Questions about this trial

What is this clinical trial studying?

A study testing Continuous Intrapartum Support in people with Cesarean Section Complications, run by IMSS Hospital General de Zona 4, Celaya, Guanajauto, Mexico at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cesarean delivery rate (time frame: Until the occurrence of delivery (expected range from 6 hours to 12 hours)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04086277, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2019.

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Clinical Trial NCT04086277 | AzTrials