Labour Augmentation by Means of Oxytocin - Obstetric Outcome and Women's Experiences

NCT01263158 | Completed

• 1 other identifier: L586-97
• Study Type: interventional
• Target: 2,072
• Locations: 1 country
• Sites: 1

Brief Summary

Slow labour progress is common in nulliparous women and is associated with childbirth complications and negative birth experiences. Oxytocin augmentation is widely used to treat slow labour despite associated risks for the fetus. An ongoing debate concerns whether oxytocin should be administered directly or postponed after arrested labour. The overall aim is to study labour progress in healthy nulliparous women and to compare childbirth outcomes and experiences in women randomised to expectant versus early oxytocin augmentation for slow labour progress. The hypothesis is that it is to early to start oxytocin treatment when labour progress has been slow for 2 to 3 hours in healthy women having their first baby and therefore beneficial for childbirth outcomes to postpone oxytocin for another 3 hours. In this randomised controlled trial nulliparous women with a normal pregnancy, spontaneous onset of active labor at term, and a cervical dilatation of 4 - 9 centimetres on admission to the delivery ward were included (n=2,072). All women whose labour did not progress after amniotomy (n=630) were randomly allocated either to labour augmentation by oxytocin infusion (Early oxytocin, n=314) or to postponement of oxytocin augmentation for another three hours (Expectant, n=316). One month postpartum the women received a postal questionnaire concerning their experiences of labour and birth. All participating women gave their informed consent. Maternal and neonatal outcomes like mode of delivery, postpartum haemorrhage, perinatal lacerations, low Apgar score, need of neonatal intensive care and maternal experiences of childbirth were compared between the randomised groups.

Conditions

Slow Labour Progress

Keywords

randomised controlled trial; nulliparous women; slow labour progress; prolonged labour; oxytocin augmentation; operative delivery; childbirth experience

Outcome Measures

Primary Outcomes (1)

• Mode of delivery (spontaneous vaginal, instrumental vaginal or caesarean delivery)

Secondary Outcomes (4)

• Postpartum haemorrhage

• Sphincter lacerations

• Need of neonatal intensive care

• Maternal experiences of childbirth

Study Arms (2)

Expectant group

EXPERIMENTAL

Arrest in labour progress for 2-3 hours and no progress after amniotomy. Expectancy of standard oxytocin treatment for 3 hours.

Other: Expectancy of standard oxytocin treatment

Early oxytocin group

NO INTERVENTION

Arrest in labour progress for 2-3 hours and no progress after amniotomy. Oxytocin treatment started within 20 minutes.

Interventions

Expectancy of standard oxytocin treatment OTHER

Expectant group

Eligibility Criteria

• Age: 18 Years - 48 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Nulliparity Normal pregnancy 37+0 - 41+6 weeks Single foetus Cephalic presentation Spontaneous onset of active labour Informed consent

You may not qualify if:

• Prelabour rupture of membranes Serious maternal disease Fetal intrauterine death

Sponsors & Collaborators

• Göteborg University: lead
• Sahlgrenska University Hospital: collaborator
• Ryhov County Hospital: collaborator

Study Sites (1)

Institute of Health and Care Sciences, University of Gothenburg

Gothenburg, 40530, Sweden

Location

Related Publications (4)

• Dencker A, Berg M, Bergqvist L, Ladfors L, Thorsen LS, Lilja H. Early versus delayed oxytocin augmentation in nulliparous women with prolonged labour--a randomised controlled trial. BJOG. 2009 Mar;116(4):530-6. doi: 10.1111/j.1471-0528.2008.01962.x.

  PMID: 19250364 RESULT

• Dencker A, Berg M, Bergqvist L, Lilja H. Identification of latent phase factors associated with active labor duration in low-risk nulliparous women with spontaneous contractions. Acta Obstet Gynecol Scand. 2010 Aug;89(8):1034-9. doi: 10.3109/00016349.2010.499446.

  PMID: 20636242 RESULT

• Dencker A, Taft C, Bergqvist L, Lilja H, Berg M. Childbirth experience questionnaire (CEQ): development and evaluation of a multidimensional instrument. BMC Pregnancy Childbirth. 2010 Dec 10;10:81. doi: 10.1186/1471-2393-10-81.

  PMID: 21143961 RESULT

• Bergqvist L, Dencker A, Taft C, Lilja H, Ladfors L, Skaring-Thorsen L, Berg M. Women's experiences after early versus postponed oxytocin treatment of slow progress in first childbirth--a randomized controlled trial. Sex Reprod Healthc. 2012 Jun;3(2):61-5. doi: 10.1016/j.srhc.2012.03.003. Epub 2012 Mar 24.

  PMID: 22578752 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2010
• First Posted: December 20, 2010
• Study Start: October 1, 1998
• Study Completion: December 1, 2003
• Last Updated: August 11, 2015

Record last verified: 2015-08

Locations

SE (1)