Outpatient Labor Induction Using Oral Misoprostol in Norway
Condition: Induced; Birth; Labor, Induced
Study type: Interventional

Summary: 
      The rate of labor induction has been steadily increasing over the last years, both worldwide
      and in Norway. Norwegian women are hospitalized when prostaglandins are used to induce labor.
      In Denmark, a neighboring country to Norway, women have been offered outpatient induction of
      labor using oral misoprostol for several years.

      The overall aim of this study is to investigate if outpatient induction of labor is
      beneficial in a Norwegian setting. This includes:

        1. To investigate the clinical outcomes and feasibility of inducing in an outpatient
           setting compared to an inpatient setting in Norway

        2. To explore low-risk nulliparous women's experiences of labor induction in inpatient and
           outpatient settings.

      This is a non-randomized prospective pilot- and feasibility study, collecting data from
      electronical records. In addition, the study participants are invited to write a diary during
      the labor induction process and a questionnaire six weeks postpartum. Eligible patients
      include low-risk nulliparous women induced with low-dose oral misoprostol.
    

Detailed description: 
      The labor induction rate in Norway has increased from 10,5 % in 2000 to 26,1 % in 2019. This
      represents an important shift in the obstetric care, making labor induction one of the most
      common obstetrical interventions. The increase alters the population being induced, as it now
      includes more low-risk births compared to 20 years ago. The low risk labor inductions might
      not require the same repeated cardiotocography and inpatient care before onset of active
      labor as complicated pregnancies.

      In 2017, a 25 μg misoprostol tablet for oral administration was approved for labor induction
      in the Nordic countries. Oral administration is user friendly, and low-dose orally
      administrated misoprostol is considered to have a favorable safety profile compared to many
      other induction methods, with low risk of hyperstimulation.

      Despite the widespread knowledge of the importance of women´s labor experience for her future
      health, this aspect is rarely thoroughly explored in the vast number of studies on labor
      induction. For outpatient labor induction to work, it must be an alternative women find
      beneficial, as well as clinicians and the health care system.

      Aim

      The overall aim of this study is to investigate if outpatient induction of labor is
      beneficial in a Norwegian setting. This includes:

      Study A. To investigate the clinical outcomes and feasibility of inducing in an outpatient
      setting compared to an inpatient setting in Norway Study B. To explore low-risk nulliparous
      women's experiences of labor induction in inpatient and outpatient settings.

      Design and methods

      Study A is a prospective non-randomized multicenter pilot- and feasibility study. Data are
      collected from the patient's electronical records. Study B is a mixed methods cross-sectional
      diary study, collecting data from the participants diaries and questionnaire and their
      electronical records. Both studies include the same participants.

      In both the inpatient and outpatient regime, the women are induced with 25 μg misoprostol
      tablets administrated orally every two hours. Some of the women will be induced using a
      balloon catheter before misoprostol. In the inpatient regime, cardiotocography (CTG) will be
      performed according to standard protocol; every 4-6 hours or on indication. In the outpatient
      protocol, a CTG will be carried out before and after the administration of the first
      misoprostol. If the CTG is normal and the woman has no contractions, the woman can go home,
      provided a normal ultrasound scan from the last three weeks. An appointment will be set up no
      later than 24 hours later for a new CTG and assessment of the induction process and the
      health of the woman and fetus. If the woman goes home after this consultation, she will
      return no later than 24 hours later for inpatient labor induction if the labor does not
      start.

      Women choosing the outpatient protocol will receive oral and written information about what
      they should be aware of and when to contact the maternity ward. They are welcome to contact
      the maternity ward at any time to seek advice from a midwife with experience in labor
      induction.
    

Intervention name(s): Outpatient labor induction; Inpatient labor induction
Intervention type(s): Other; Other
Intervention description(s): The participants stay at home during til labor induction process and are admitted to hospital at the onset of labor or if a complication occur. Outpatient consultations once a day.; The participants are induced following standard inpatient care
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Labor induction; Induced birth; Outpatient; Oral misoprostol