Continuous Intrapartum Support to Reduce Primary Cesarean

NCT ID: NCT04086277

Last Updated: 2019-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2018-12-31

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.

Conditions

Cesarean Section Complications

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Continuous Intrapartum Support

Intervention Type: 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.

Women in labor without continuous intrapartum support.

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fondo de Investigación en Salud (FIS), México

UNKNOWN

Sponsor Role: collaborator

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

OTHER_GOV

Sponsor Role: lead

Responsible Party

Luz Maria Cardona Torres

Subjefe de Educación e Investigación en Salud

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luz M Cardona, Master

Role: PRINCIPAL_INVESTIGATOR

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

Locations

IMSS Hospital General de Zona 4

Celaya, Guanajuato, Mexico

Countries

Mexico

References

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 28681500 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28854903 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18507579 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20152972 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19128863 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30522458 (View on PubMed)

Other Identifiers

LMCT-02

Identifier Type: -

Identifier Source: org_study_id