Clinical trial NCT04086277: Continuous Intrapartum Support to Reduce Primary Cesarean
Official title: Continuous Intrapartum Support to Reduce Primary Cesarean
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section Complications
Keywords: cesarean section
Continuous intrapartum support
nulliparous
Lead sponsor: IMSS Hospital General de Zona 4, Celaya, Guanajauto, Mexico
Sponsor class: OTHER_GOV
Collaborators: name: Fondo de Investigación en Salud (FIS), México
First posted: 2019-09-11
Enrollment: 115
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Cesarean delivery rate
timeFrame: Until the occurrence of delivery (expected range from 6 hours to 12 hours)
Secondary outcomes:
measure: Time of labour
timeFrame: From the active phase up to delivery (expected range from 6 hours to 12 hours)
measure: Apgar score
timeFrame: At 1 and 5 minutes after delivery
measure: Obstetric analgesia
timeFrame: From the active phase up to delivery (expected range from 6 hours to 12 hours)
measure: Induction of labour
timeFrame: start of active phase (up to 1 hour)
Other outcomes:
Locations:
city: Celaya
country: Mexico
facility: IMSS Hospital General de Zona 4
state: Guanajuato
Study officials:
affiliation: IMSS Hospital General de Zona 4, Celaya, Guanajauto, México
name: Luz M Cardona, Master
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.
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.
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.
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.