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Completed

NCT Number: NCT04746248

Outpatient Labor Induction Using Oral Misoprostol in Norway

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.

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Key information

Age range

18 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Vestre Viken Health Trust, Drammen Hospital, Drammen, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy nulliparous women
  • A single, healthy fetus in cephalic presentation at gestational age of 37 weeks or more
  • Normal pregnancy
  • The woman can read and communicate in Norwegian
  • No cognitive barriers
  • BMI 15,5-39,9
  • Reside within one hour from the hospital
  • Indication for labor induction is post term pregnancy, uncomplicated pre labor rupture of membranes, maternal wish or other indications determined as low-risk by the attending obstetrician

Exclusion criteria

  • Known uterine abnormality or previous uterine surgery
  • Major maternal medical illness requiring monitoring of mother or fetus in early labor
  • Maternal infection
  • Pregnancy complications such as preeclampsia, poorly controlled hypertension or medically treated diabetes mellitus
  • Active vaginal bleeding characterized as more than bloody show
  • Smoking
  • Non-reassuring cardiotocography or reduced fetal movement
  • Fetal growth EFW < 10th percentile or >90th percentile
  • Poly- or oligohydramnios
  • Known abnormalities in the placenta or umbilical cord

Treatment and study plan

Outpatient labor induction

Other

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.

Inpatient labor induction

Other

The participants are induced following standard inpatient care

Primary outcomes

  1. The proportion of eligible women selecting outpatient labor induction

    Time frame: up to 18 months

  2. Fetal metabolic acidosis

    Time frame: From delivery and within two hours postpartum

    The proportion of fetal metabolic acidosis

  3. Deliveries outside the hospital

    Time frame: At time of delivery

    The proportion of deliveries outside the hospital in the outpatient versus inpatient induction group

Secondary outcomes

  1. Delivery mode

    Time frame: At the time of delivery

    Mutually exclusive categories, either spontaneous vaginal birth, either instrumental vaginal birth, either operative delivery by cesarean section

  2. Indications for operative delivery

    Time frame: At the time of delivery

    Indications for cesarean delivery or operative vaginal delivery

  3. Uterine rupture

    Time frame: During labor induction or birth

  4. Maternal admission to ICU or maternal death

    Time frame: From start of induction through discharge, normally within 2-4 days after delivery

  5. Maternal hemorrhage (in ml)

    Time frame: During birth and until two hours after delivery

  6. Chorioamnionitis

    Time frame: During birth and until two hours after delivery

    Number of participants with clinical chorioamnionitis

  7. Perineal injury

    Time frame: At the time of delivery

    Perineal third or forth degree lacerations and epiosotomy

  8. Perinatal death

    Time frame: From start of induction until 1 week after delivery

  9. Need for neonatal resuscitation after delivery

    Time frame: Within two hours after delivery

  10. Uterine tachysystole

    Time frame: From start of induction until delivery

  11. Admission to NICU due to birth related issues

    Time frame: From delivery until discharge, usually 2-4 days after delivery, maximum of 1 week postpartum

  12. Apgar score

    Time frame: 1, 5 and 10 minutes after delivery

    Score 0 to 10 where 10 is highest score indicating most vital neonate

  13. Umbilical cord pH and pCO2

    Time frame: Immediately after delivery

  14. Presence of meconium in amniotic fluid

    Time frame: From start of induction until delivery

  15. Duration of the stages during induction and birth

    Time frame: From start of induction until transfer top postpartum ward

    Time from start of medication to start of active labor, labor duration, duration of hospital stay

  16. Contact with the hospital during the labor induction process

    Time frame: From start of induction until hospital admission

    Counting number of contacts adding up to a total

  17. Misoprostol administration

    Time frame: From start of induction until start of active labor

    Total misoprostol dose, delay of medicament administration

  18. Need for other interventions to induce or augment labor

    Time frame: From start of induction until start of active labor

  19. The experience of labor induction

    Time frame: 6-8 weeks postpartum

    The Experiences of Induction Tool (EXIT), a validated instrument to measure the experiences of labor induction Minimum score per item is 1, maximum is 5, the higher the score the more positive the experience.

  20. The experience of childbirth

    Time frame: 6-8 weeks postpartum

    The Childbirth Experience Questionnaire (CEQ), a validated instrument to measure the experience of childbirth, 4 domains, mean for each domain will be calculated and compared, the higher mean per domain the more positive the birth experience, lowest mean per domain is 1 highest is 4.

  21. Postnatal depression

    Time frame: 6-8 weeks postpartum

    The Edinburgh Postnatal Depression Scale-short version (EPDS-5), Minimum score 0, maximum score 15, cut-off 7 or more The higher the score the more symptoms of depression

  22. The Early Labor Experience

    Time frame: From start of induction until delivery and 6-8 weeks postpartum

    Swedish Early Labor Questionnaire for primiparous women (SWE-ELEQ-PP), a validated instrument to measure measure the experience of early labor, 22 items mean score is calculated, higher score is better experience, minimum score per items is 1 maximum is 5

Sponsors and collaborators

Lead sponsor

Oslo Metropolitan University

Other

Collaborators

  • Oslo University Hospital
  • Vestre Viken Hospital Trust

Registry information

Official study title

The LINO Study - Labor Induction Inpatient and Outpatent: A Pilot- and Feasibility Study of Low-risk Nulliparious Women Using 25 mcg Oral Misoprostol for Labor Induction in an Inpatient and Outpatent Setting in Norway.

Acronym: LINO

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 9, 2021
Registry last updated
Mar 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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