Amniotomy and Oxytocin for Augmentation of Labour
NCT02318121 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2017-11-21
Summary
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.
Conditions
- Prolonged Labor
Interventions
- PROCEDURE
-
Amniotomy first
rupture of membranes to augment labor
- PROCEDURE
-
Oxytocin first
Administration of oxytocin to augment labor
- PROCEDURE
-
Amniotomy and oxytocin
Rupture of membranes and administration of oxytocin to augment labor
- DRUG
-
Oxytocin
Sponsors & Collaborators
-
Assiut University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 35 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-04-01
- Primary Completion
- 2014-09-01
- Completion
- 2015-12-01
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