Clinical trial NCT04746248: Outpatient Labor Induction Using Oral Misoprostol in Norway
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Induced; Birth
Labor, Induced
Keywords: Labor induction
Induced birth
Outpatient
Oral misoprostol
Lead sponsor: Oslo Metropolitan University
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
name: Vestre Viken Hospital Trust
First posted: 2021-02-09
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: The proportion of eligible women selecting outpatient labor induction
timeFrame: up to 18 months
measure: Fetal metabolic acidosis
timeFrame: From delivery and within two hours postpartum
measure: Deliveries outside the hospital
timeFrame: At time of delivery
Secondary outcomes:
measure: Delivery mode
timeFrame: At the time of delivery
measure: Indications for operative delivery
timeFrame: At the time of delivery
measure: Uterine rupture
timeFrame: During labor induction or birth
measure: Maternal admission to ICU or maternal death
timeFrame: From start of induction through discharge, normally within 2-4 days after delivery
measure: Maternal hemorrhage (in ml)
timeFrame: During birth and until two hours after delivery
measure: Chorioamnionitis
timeFrame: During birth and until two hours after delivery
measure: Perineal injury
timeFrame: At the time of delivery
measure: Perinatal death
timeFrame: From start of induction until 1 week after delivery
measure: Need for neonatal resuscitation after delivery
timeFrame: Within two hours after delivery
measure: Uterine tachysystole
timeFrame: From start of induction until delivery
measure: Admission to NICU due to birth related issues
timeFrame: From delivery until discharge, usually 2-4 days after delivery, maximum of 1 week postpartum
measure: Apgar score
timeFrame: 1, 5 and 10 minutes after delivery
measure: Umbilical cord pH and pCO2
timeFrame: Immediately after delivery
measure: Presence of meconium in amniotic fluid
timeFrame: From start of induction until delivery
measure: Duration of the stages during induction and birth
timeFrame: From start of induction until transfer top postpartum ward
measure: Contact with the hospital during the labor induction process
timeFrame: From start of induction until hospital admission
measure: Misoprostol administration
timeFrame: From start of induction until start of active labor
measure: Need for other interventions to induce or augment labor
timeFrame: From start of induction until start of active labor
measure: The experience of labor induction
timeFrame: 6-8 weeks postpartum
measure: The experience of childbirth
timeFrame: 6-8 weeks postpartum
measure: Postnatal depression
timeFrame: 6-8 weeks postpartum
measure: The Early Labor Experience
timeFrame: From start of induction until delivery and 6-8 weeks postpartum
Other outcomes:
Locations:
city: Drammen
country: Norway
facility: Vestre Viken Health Trust, Drammen Hospital
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
References: