Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
150 participants
INTERVENTIONAL
2014-04-01
2015-12-01
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Amniotomy first
Will be done with sterile gloves after insurance that is the baby's head fits in the pelvis ( 3\\5 or less of fetal head felt by first pelvic grip ) and by vaginal examination the head at station zero . The membranes are then punctured using an a hook during uterine contractions.
Amniotomy first
rupture of membranes to augment labor
Oxytocin first
The starting dose will be the low dose rate equal or less than 4 m unit\\minute (4 drops\\minute doubled every 15 minutes up to 40 drops \\minute) as intravenous drip on dextrose ,Ringer's lactate or saline solution.
Oxytocin first
Administration of oxytocin to augment labor
Oxytocin
Amniotomy and oxytocin
Amniotomy will be done (as explained above) and oxytocin (the same regimen mentioned above) at the same time.
Amniotomy and oxytocin
Rupture of membranes and administration of oxytocin to augment labor
Oxytocin
Interventions
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Amniotomy first
rupture of membranes to augment labor
Oxytocin first
Administration of oxytocin to augment labor
Amniotomy and oxytocin
Rupture of membranes and administration of oxytocin to augment labor
Oxytocin
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
35 Years
FEMALE
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Omar Mamdouh Shaaban
Dr.
Other Identifiers
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Augmentation of labour
Identifier Type: -
Identifier Source: org_study_id