Continuous Intrapartum Support to Reduce Primary Cesarean

Cesarean Section Complications Clinical Trial

Official title:

Continuous Intrapartum Support to Reduce Primary Cesarean

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04086277
• Other study ID #: LMCT-02
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: September 2019
• Source: IMSS Hospital General de Zona 4, Celaya, Guanajauto, Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 4 of the Guanajuato delegation of the Mexican Institute of Social Security, Mexico

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years to 40 Years

Eligibility

Inclusion Criteria:

• Women pregnant

• Nulliparous

• Term pregnancy

• Singleton pregnancy

• Vertex position

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Cesarean Section Complications

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Mexico	IMSS Hospital General de Zona 4	Celaya	Guanajuato

Sponsors (2)

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

Country where clinical trial is conducted

Mexico, 

References & Publications (7)

Bohren MA, Hofmeyr GJ, Sakala C, Fukuzawa RK, Cuthbert A. Continuous support for women during childbirth. Cochrane Database Syst Rev. 2017 Jul 6;7:CD003766. doi: 10.1002/14651858.CD003766.pub6. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cesarean delivery rate	Percentage de cesarean section in the arms	Until the occurrence of delivery (expected range from 6 hours to 12 hours)
Secondary	Time of labour	Labour covered the period of time from the active phase to birth. (Hours)	From the active phase up to delivery (expected range from 6 hours to 12 hours)
Secondary	Apgar score	Is a quick test performed on a baby at 1 and 5 minutes after birth	At 1 and 5 minutes after delivery
Secondary	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)	From the active phase up to delivery (expected range from 6 hours to 12 hours)
Secondary	Induction of labour	If oxytocin was used to induce labour. (Yes/No).	start of active phase (up to 1 hour)