Induction of Labor in Term Premature Rupture of Membranes: A Comparison Between Oxytocin and Dinoprostone Followed Six Hours Later by Oxytocin
Condition: Labor; Induction; PROM (Pregnancy)
MeSH terms: Fetal Membranes, Premature Rupture
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    


Intervention name(s): SYNPITAN FORT 5 IU; Propess,SYNPITAN FORT
Intervention type(s): Drug; Drug
Intervention description(s): A standard intravenous oxytocin was administered 6 hours after the insertion of the vaginal pessary. An initial dose of 2 mU/min was increased at 30 minute intervals by 2 mU/min to a maximum dose 32 mU/min or until four contractions in 10 minutes was achieved. Once started, oxytocin infusion was continued to delivery unless otherwise indicated. The pessary has been removed if it was still present 12 h after placement; or if worrisome FHR pattern persisted; a single dose sustained-released dinoprostone into the posterior vaginal fornix. A standard intravenous oxytocin was administered 6 hours after the insertion of the vaginal pessary. An initial dose of 2 mU/min was increased at 30 minute intervals by 2 mU/min to a maximum dose 32 mU/min or until four contractions in 10 minutes was achieved
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: induction of labor in term; premature rupture of membranes; dinoprostone; oxytocin