Comparison of Two Rhythm of Administration of Prostaglandin Gel for Induction of Labor
Condition: Labor Complication; Cervix
MeSH terms: Obstetric Labor Complications
Study type: Interventional
Phase: Phase 2

Summary: 
      The study compares two rhythms of administration of prostaglandin vaginal gels for cervical
      priming before induction of labor in term patients. In our institution, prostaglandin gels
      are given for a maximum of three times, with induction by oxytocin and amniotomy the day
      after the last gel whatever Bishop score has been obtained. This management results in some
      patient spending four days in hospital before delivery. The aim of the study is to compare
      our classical management scheme with a reduced interval between to gels, of 12h instead of 24
      h. The primary outcome will be the time elapsed between the first prostaglandin gel and
      delivery. Tolerance of both management patterns will also be evaluated through a satisfaction
      survey.
    

Detailed description: 
      Approximatively 22% of pregnant women have an induction of labor in France (22.9% in our
      institution in 2019), mainly for prolonged pregnancy after 41 weeks gestational age or
      prolonged rupture of membranes. Patients whose cervix is considered unripe (Bishop score
      under 6) are generally proposed a cervical priming because induction of labor without prior
      priming entails a higher of cesarean delivery rate for failed induction. The devices used for
      cervical priming are pharmacological (mainly prostaglandin gel, pessaries or suppositories)
      or mechanical (Foley catheter, Cook balloons). Very few recommendations exist regarding the
      type of device, the rhythm and maximal number of repeat administrations and the interval
      between two administrations. Shortening interval between two administrations (in case of use
      of a device necessitating serial prescriptions) may shorten the time interval between
      beginning of priming and delivery. In our institution, a vaginal gel can be given three times
      before induction of labor with oxytocin and amniotomy, whatever Bishop score has been
      obtained after priming. These gels are given on a daily basis. This rhythm implies than for
      some women not responding to a first gel, priming can last up to three days, lengthening
      hospital stay and leading to maternal weariness. Maternal satisfaction during induction of
      labor is seldom analyzed. An intensification in gel administration implies a change in
      maternal management during the induction process, with shortened periods of rest between two
      gels and nearer periods of pain and discomfort, albeit on a theoretically shorter period. The
      way patients deal with this new rhythm compared to the classical in part of the evaluation in
      this study. All patients having a singleton pregnancy and an indication for term (≥ 37 weeks
      gestation age) induction with an unfavorable cervix and no contraindication to vaginal
      delivery will be eligible. Patients with fetuses in breech presentation, a scarred uterus,
      under 18 years, bearing a fetus with antenatally known malformation, not fluent in French or
      presenting an allergy to prostaglandins will be excluded. A written informed consent will be
      required before inclusion. The primary outcome will be the duration between first priming
      with prostaglandin gel and delivery. Secondary outcomes will be the satisfaction of patients
      with their induction process (measured through a survey answered during the in-hospital
      post-partum stay), the rate of cesarean section, the rate of hypertonia/hypercinesia during
      priming and induction requiring medical intervention, the length of active phase of labor
      (after 5 cm of dilation), the oxytocin doses used during delivery for induction or
      augmentation, initial neonatal (Apgar score, arterial cord pH and lactates, resuscitation
      maneuvers, transfer to intensive care unit) and maternal (post-partum hemorrhage,
      hyperthermia during labor, perineal laceration > 2nd degree and endometritis) morbidity and
      length of total hospital stay. The investigators calculated that a sample of 268 patients
      (134 in each group) will be necessary to detect a 30% reduction in duration between first
      priming and delivery in the experimental group (one gel every 12h) compared with the
      classical group. Mean time frame between first priming and delivery has been measured in our
      department in 2018 to 31.8 hours (standard deviation 27.6 hours).
    

Intervention name(s): Dinoprostone vaginal gel
Intervention type(s): Drug
Intervention description(s): Prostaglandin gel 0.5, 1 or 2 mg
Other intervention name(s): cervical priming with prostaglandin gel
Intervention MeSH terms: Dinoprostone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Induction; Term; Labor; Rhythm; Prostaglandins