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NCT Number: NCT02318121

Amniotomy and Oxytocin for Augmentation of Labour

Prolonged labour is a cause of maternal mortality and morbidity and perinatal mortality and morbidity. Prolonged labour is most often defined as onset of regular , rhythmical painful contractions accompanied by cervical dilatation where labour is longer than 24 hours.prolonged active phase should not last longer than 12 hours without full assessment in a facility able to offer management and treatment of complications.Causes of prolonged labour usually due to poor or uncoordinated uterine action , fetal head malposition , and or abnormal pelvis either due to bone or soft tissue obstruction.

Arrested or prolonged labor is a frequent indication of cesarean delivery.Prolonged labor is also associated with increased pain and negative birth experience. Women with a prolonged first stage of labor have experienced a higher rate of postpartum hemorrhage, chorioamnionitis and neonatal admission to the intensive care unit.

Caesarean section rates are over 20% in many developed countries and have increased nearly four-fold relative to the 5% rate observed in the early 1970s. The main diagnosis contributing to this increase is dystocia or prolonged labor.Data obtained from local hospital records showed that Caesarean section rate in Assiut University Women's Health Hospital is 47.96% at 2013.

Dystocia is a term used for delay of labor progress and usually refers to abnormally slow cervical dilatation.It has been proposed that the partogram should include, as a diagnostic criterion, a 1 cm/hour line originating at admission. The World Health Organization has proposed a modified partogram that recommends that active phase be diagnosed only at 4 cm or more.

Oxytocin augmentation of uterine contractions with or without amniotomy is widely used in the modern obstetric practice to treat a slow labour, although the timing of oxytocin initiation and amniotomy may vary widely.This intervention is based on the hypothesis that the most frequent cause of dystocia is inadequate uterine contraction.

The mechanism by which amniotomy speeds up labour remains unclear it is thought that when the membranes are ruptured ,the production and release of prostaglandins and oxytocin increases resulting in stronger contractions and quicker cervical dilatation. I has been found that early intervention (augmentation versus routine care ) with amniotomy and oxytocin to be associated with a modest reduction in the risk of caesarean section. Moreover, amniotomy found to be associated with an increased risk of cesarean delivery compared with women without amniotomy for shortening of spontaneous labour.

The 3 methods ( Amniotomy, Oxytocin or both) used for augmentation of labor in different settings without a real conclusion which is better.

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Key information

Conditions

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women in spontaneous labor
  • Women with intact membranes at the time of randomization
  • Single fetus
  • Vertex presentation
  • Cervical dilatation 3 cm or more
  • Gestational age 37 weeks or more proved by reliable dates or by early ultrasound scan in the first trimester
  • Slow progress in the active phase of labor ( cervical dilatation less than 1 cm \\hour)

Exclusion criteria

  • Women with a previous uterine scar
  • Severe preeclamptic toxemia
  • Suspected fetal macrosomia (greater than 4000 g)
  • Women with any congenital malformations
  • Women with Intra uterine fetal death
  • Diabetes mellitus with pregnancy
  • Antepartum hemorrhage
  • Women with other indications of caesarean section

Treatment and study plan

Amniotomy first

Procedure

rupture of membranes to augment labor

Oxytocin first

Procedure

Administration of oxytocin to augment labor

Amniotomy and oxytocin

Procedure

Rupture of membranes and administration of oxytocin to augment labor

Oxytocin

Drug

Primary outcomes

  1. Rate of cervical dilatation

    Time frame: every hour up to full cervical dilatation

    The rate of cervical dilation cm/ hour

Secondary outcomes

  1. Augmentation delivery time

    Time frame: Time ( in minutes) between the start of augmentation of labor up to the delivery of the head

    the duration between Augmentation of labor and the end of the second stage if labor

  2. Apgar score at 10 minutes

    Time frame: from 0-10 minutes

    Assessment of Apgar score of the baby at 10 minutes after delivery

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Concurrent Versus Sequential Administration of Amniotomy and Oxytocin for Augmentation of Labour: a Randomized Controlled Trial

Acronym: AOAL

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Dec 17, 2014
Registry last updated
Nov 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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