Oral Misoprostol for Outpatient Induction of Labor
Condition: Labor Induction
Study type: Interventional

Summary: 
      An increasing proportion of pregnant women have their labors induced due to changing
      guidelines. In correlation with this increase, the population of the induced women has
      changed toward more women with a low-risk pregnancy. Traditionally, induction of labor has
      taken place in an inpatient setting where the women have spent extra days in hospital before
      delivery.

      Oral prostaglandins, such as misoprostol, is one of the most commonly used induction agent
      and is easy for the pregnant women to administrate. The pharmacological effect is ripening
      the cervix and compared to the mechanical cervical ripening, with a balloon catheter, the
      demands on busy maternity services seems reduced. Before contractions start, the risk of
      adverse effects on mother or fetus is considered low, but the evidence on use of misoprostol
      in an outpatient setting is sparse.
    

Detailed description: 
      The implementation of induction of labor in outpatient settings is increasing despite
      insufficient evidence regarding safety and effectiveness. The use of a balloon catheter in an
      outpatient setting is not associated with adverse outcomes in a low-risk population. There is
      also evidence that outpatient vs inpatient induction of labor with balloon catheter is
      equally effective. Examination of vaginal dinoprostone (prostaglandin E2) is found to be
      efficacious in outpatient settings. However, strong evidence concludes that the oral route of
      administration of prostaglandin is preferable when inducing labor. The World Health
      Organization recommend 25ug misoprostol (prostaglandin E1) orally every 2 hour until
      contractions start for induction of labor.

      The women randomized to an inpatient setting will receive the hospital standard follow-up;
      oral misoprostol 25ug every two hours and a cardiotocography for fetal monitoring every 4-6
      hour until start of contractions for two days.

      The women randomized to an outpatient setting will receive one oral misoprostol 25ug at the
      maternity unit. After two hours, provided a normal cardiotocography and no contractions, they
      can go home. They will continue to take 25ug misoprostol every two hours until start of
      contractions or increasing pain. Maximum time spent at home will be 48 hours.

      A dedicated midwife on call will always be available for questions. The women will receive
      oral and written information to return to the maternity unit if the water breaks, if they
      experience increasing pain or bleeding, if they feel insecure or anxious, if there are
      reduced or no fetal movements, and/or when the contraction starts. When the woman returns,
      she will stay admitted until delivery.

      All women will be given standard of care and fetal surveillance when admitted to the
      hospital, when the contractions start or if the contractions are still absent after 48 hours.
      We will also ask eligible women who refrain to participate about their reasons for
      non-participation.

      PRIMARY RESEARCH QUESTION We aim to explore that induction of labor using oral misoprostol
      appears feasible in an outpatient setting and may positively influence the length of the
      hospital stay and maternal satisfaction.

      PRIMARY RESEARCH PLAN This is a pilot study to explore the feasibility of a possible
      multicenter randomized controlled trail.
    

Intervention name(s): Inpatient setting; Outpatient setting
Intervention type(s): Other; Other
Intervention description(s): These women stay at the hospital.; These women can leave the hospital.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: All eligible women will be recruited form a midwife and/or doctor. After the inclusion they will be randomized to either inpatient or outpatient setting.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: induction of labor; outpatient setting; misoprostol