Induction of labour in women with term premature rupture of membranes.

• Register: PACTR
• Last refreshed on: 29 April 2013
• Main ID: PACTR201211000447393
• Date of registration: 30/10/2012
• Primary sponsor: Department of Obstetric and Gynecology
• Public title: Induction of labour in women with term premature rupture of membranes.
• Scientific title: Oxytocin versus concurrent use of oxytocin and rectal misoprostol for induction of labour in women with term premature rupture of membranes:A randomised controlled trial
• Date of first enrolment: 2012-10-10
• Target sample size: 110
• Recruitment status: Open to recruitment: actively recruiting participa
• URL: HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201211000447393
• Study type: interventional
• Study design: Parallel: different groups receive different interventions at same time during study,; Randomised,; Simple randomisation using a random table from a statistics book,; Sealed opaque envelopes,

Countries of recruitment

South Africa

Contacts

• Name: Alaa Masoud
• Affiliation: Lecturer in Obstetrics and Gynecology (Menoufiya University)

• Name: Mohamed Emara
• Affiliation: Lecturer in Obstetrics and Gynecology (Menoufiya University)

Key inclusion & exclusion criteria

Inclusion criteria: Confirmed gestational age (32-42 weeks gestation)determined last menstrual period or by ultrasound scan in the 1st trimester.
A singleton pregnancy with normal fetus in vertex presentation.
Premature rupture of membranes confirmed by visualizing a pool of amniotic fluid at a sterile speculum examination and AFI less than 5.
Absence of other indications for urgent induction of labor
No signs of active labor, no abdominal pain on admission.
Exclusion criteria: Known hypersensitivity or any contraindications to prostaglandins (e.g.gluoma or sickle cell disease).
Multiple pregnancy.
Multiparity
Contraindication to vaginal birth such as previous uterine surgery, contracted pelvis or malpresentation.
Estimated fetal weight more than 4 kg or less than 2 kg
Placenta previa or unexplained vaginal bleeding.
Evidence of chorioamnionitis.
Medical diseases e.g. cardiovascular disease or chronic renal failure.


Age minimum: 19 Year
Age maximum: 33 Year
Gender: Female

Health Condition(s) or Problem(s) studied

Induction of labour in pregnant women with term premature rupture of membranes.

Primary Outcome(s)

The number of women who will succeed in delivering vaginally

Secondary Outcome(s)

Incidence of excess uterine activity,labor induction to delivery interval, meconium stained liquor and mode of delivery

Source(s) of Monetary Support

Menoufiya University Hospitals