Labor Clinical Trial
Prelabor rupture of membranes (PROM) is most commonly defined as rupture of membranes before
the onset of labor and occurs in 8% of term pregnancies. A prolonged interval from rupture
of membranes to delivery is associated with an increase in the incidence of chorioamnionitis
and neonatal sepsis. The management of the term patients with PROM, especially those with an
unfavorable cervix, remains controversial. Management options to choose from are immediate
induction of labor versus delayed induction or expectant management. Several reports have
detailed an increase in maternal and neonatal morbidity with expectant management, whereas
active management leads to a shorter interval from PROM to delivery, reducing the risk of
postnatal infections. In addition, active management is preferred by patients.
The investigators know that, neonatal intensive care admission, variable decelerations, and
primary cesarean delivery rates are positively correlated with a longer
admission-to-labor-onset interval in women with PROM . So, to reduce the induction to
delivery times, concurrent oxytocin infusion with dinoprostone vaginal pessary use for labor
induction in women with PROM may be beneficial. Several studies have shown shorter
induction-to-delivery interval with concurrent oxytocin infusion with prostaglandin agent at
initiation of labor . However, in these studies, there is a a paucity information in PROM
labor induction. Only one randomized control trial have compared the efficacy of concurrent
dinoprostone and oxytocin and oxytocin alone in women with term PROM . This study indicated
that concurrent vaginal dinoprostone and intravenous oxytocin conferred no advantage over
intravenous oxytocin alone for the outcomes of interest, including length of labor patient
satisfaction or risk for cesarean delivery. Unfortunately, this study was limited by small
sample size.
The aims of this randomized study was to compare two protocols (oxytocin vs.
sustained-release dinoprostone followed six hours later by oxytocin) for induction of labour
in women with PROM at term and an unfavorable cervix.
Status | Completed |
Enrollment | 225 |
Est. completion date | November 2010 |
Est. primary completion date | November 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Women with a live singleton fetus at term [37-42 weeks of gestation in cephalic presentation - reactive nonstress test (NST) - presenting with PROM - a Bishop score of 5 or less before the onset of labor - an absence of spontaneous contractions Exclusion Criteria: - Women in active labor - previous uterine surgery, - antepartum hemorrhage, - chorioamnionitis, - contraindication to prostaglandin use (bronchial asthma, glaucoma), *contraindication to vaginal delivery, - multiple pregnancy, - non-vertex presentation - major fetal anomalies |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Turkey | Bakirkoy Women and Children Hospital | Istanbul | Yanimahalle |
Lead Sponsor | Collaborator |
---|---|
Erzincan Military Hospital |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the number (rate) of women who succeeded in delivering vaginally within 24 h of the initiation of the labor induction protocol | 24 hours | Yes | |
Secondary | labor induction-to-delivery interval | 48 hours | Yes |
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