Outpatient labor induction
OtherThe 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.
NCT Number: NCT04746248
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.
Looking for future studies?
Notify Me18 year–42 year
Female
Interventional
Not applicable
Vestre Viken Health Trust, Drammen Hospital, Drammen, Norway
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: up to 18 months
Time frame: From delivery and within two hours postpartum
The proportion of fetal metabolic acidosis
Time frame: At time of delivery
The proportion of deliveries outside the hospital in the outpatient versus inpatient induction group
Time frame: At the time of delivery
Mutually exclusive categories, either spontaneous vaginal birth, either instrumental vaginal birth, either operative delivery by cesarean section
Time frame: At the time of delivery
Indications for cesarean delivery or operative vaginal delivery
Time frame: During labor induction or birth
Time frame: From start of induction through discharge, normally within 2-4 days after delivery
Time frame: During birth and until two hours after delivery
Time frame: During birth and until two hours after delivery
Number of participants with clinical chorioamnionitis
Time frame: At the time of delivery
Perineal third or forth degree lacerations and epiosotomy
Time frame: From start of induction until 1 week after delivery
Time frame: Within two hours after delivery
Time frame: From start of induction until delivery
Time frame: From delivery until discharge, usually 2-4 days after delivery, maximum of 1 week postpartum
Time frame: 1, 5 and 10 minutes after delivery
Score 0 to 10 where 10 is highest score indicating most vital neonate
Time frame: Immediately after delivery
Time frame: From start of induction until delivery
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
Time frame: From start of induction until hospital admission
Counting number of contacts adding up to a total
Time frame: From start of induction until start of active labor
Total misoprostol dose, delay of medicament administration
Time frame: From start of induction until start of active labor
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.
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.
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
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
Oslo Metropolitan University
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)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.
Published trials that share one or more normalized conditions with this study.
NCT05100264
Induced; Birth, Labor, Induced
Athens, Greece
View Trial DetailsNCT05671224
Induced; Birth
St Louis, Missouri, United States
View Trial DetailsNCT06623175
Acupuncture, Cervical Ripening
Modena, Italy
View Trial DetailsNCT03670836
Induced; Birth, Labor Onset and Length Abnormalities
New York, United States
View Trial Details