Induction of LaborNCT05144048
Outpatient Induction of Labor With Oral Misoprostol
A study testing Inpatient setting and Outpatient setting in people with Induction of Labor, run by Sorlandet Hospital HF at 5 sites in Norway.
Trial summary
Induction of labor is an increasingly used intervention in obstetrics due to expanding indications, which more often includes relatively healthy women with uncomplicated pregnancies. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Induction of Labor
- What is being tested?
- Inpatient setting and Outpatient setting
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 5 sitesNorway
- Study dates
- 1 Jan 2022to 29 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 37 gestational weeks, vertex presentation, single pregnancy
- Age ≥ 18 years
- Understand and read Norwegian
- Distance to hospital less than 1 hour
- Normal ultrasound including:
- fetal movements
Show all 11Show fewer
- amniotic fluid (deepest single vertical pocket) > 2 cm
- estimated fetal weight ≥ -15% (≥ 10 percentile)
- Normal antenatal cardiotocography
- Women with stable hypertension and uncomplicated preeclampsia without indication for inpatient treatment can be included after individual assessment.
- Access to partner or contact person at home for transportation to hospital
Who cannot join
- Premature rupture of membranes
- Uterine scar
- BMI ≥ 40
- Abnormal fetal Doppler (if examined); umbilical artery pulsatility index ≥ 95 percentile and/or cerebroplacental ratio <1
- Fetal anomaly or chromosomic / genetic disorder
- Grand multipara (P≥4)
Show all 11Show fewer
- Cognitive barriers
- Pregnancy complications such as preeclampsia requiring in-hospital treatment, insulin dependent diabetes or other conditions associated with risk of fetal hypoxia during labor
- Signs of infection or serious health problems
- Favorable cervix and / or previous obstetric history providing contraindications for induction with misoprostol
- Combined risk factors, individually evaluated by the attending obstetrician
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Norway5 sites
Haukeland University Hospital
Bergen
Nordlandssykehuset HF
Bodø
Østfold Hospital Trust
Fredrikstad
Sorlandet Hospital Trust
Kristiansand, 4604
St. Olavs Hospital
Trondheim
About this study
Official title: Outpatient Induction of Labor With Oral Misoprostol: A Multicenter Randomized-controlled Trial
Induction of labor is an increasingly used intervention in obstetrics due to expanding indications, which more often includes relatively healthy women with uncomplicated pregnancies. While induction of labor traditionally is offered in an inpatient setting, a shift towards an outpatient setting is increasing despite insufficient evidence regarding safety and effectiveness. Oral misoprostol is easy for the pregnant women to administer and the risk of uterine hyperstimulation with fetal heart rate changes is found to be low. Strong evidence concludes that oral misoprostol is preferable as an induction agent and is recommended by the World Health Organization (WHO).
The investigators will perform a multicenter randomized-controlled trial comparing labor induction in an outpatient versus inpatient setting, aiming to increase knowledge on outpatient induction of labor with oral misoprostol. The study is based on experiences and findings from a recently performed pilot trial and targets a large group of relatively healthy pregnant women where induction of labor is decided.
The investigators hypothesize that women induced in an outpatient setting will be more satisfied than women induced in an inpatient setting.
Read the detailed description
After induction of labor is decided the women will be recruited according to inclusion and exclusion criteria's.
The inpatient induction group will receive the following treatment:
Oral misoprostol 25ug every two hours and a cardiotocography for fetal monitoring every 4-6 hours until start of contractions, the next 48 hours while admitted to the maternity ward. The participating women will be transferred to the labor ward by start of contractions or need for closer fetal surveillance and/or analgesia.
The outpatient induction group will receive the following treatment:
These participating women receive the first oral misoprostol 25ug at the maternity unit. After two hours if the cardiotocograph is normal and there are no signs of contractions, these women go home. At home, the women will continue to take 25ug misoprostol every two hours until 22 pm or until the contractions begin. Maximum time spent at home is 48 hours and maximum number of tablets is 12 during this period (6 tablets each day). The women will also receive oral and written information regarding when to return to the maternity ward. Information sheets for the midwives and included women will be adapted from those used in the pilot study.
If the contractions are still absent after 48 hours or a maximum of 12 tablets (6 per day), all women (both inpatient and outpatient) are admitted to the maternity ward for further induction of labor. All women will receive equal standard of care including fetal surveillance after admittance to the hospital. Further follow up is in accordance with standard procedure of the maternity ward. Questions about fidelity to the proposed protocol across sites will be asked in the patient questionnaire.
- Conditions
- Induction of Labor
- Being tested
- Inpatient setting, Outpatient setting
- Keywords
- induction, outpatient, misoprostol, childbirth experience
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inpatient settingOther
These women stay at the maternity unit
Outpatient settingOther
These women leave the maternity unit
| Study group | Role | What they receive |
|---|---|---|
| Induction of labour with oral misoprostol, inpatient setting | Active comparator | These women receive all treatment in the maternity unit. Receives: Other: Inpatient setting |
| Induction of labour with oral misoprostol, outpatient setting | Experimental | These women are observed 2 hours after they receive one dose of oral misoprostol before they leave the maternity unit. Receives: Other: Outpatient setting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal childbirth experience and maternal experience with induction of labor
The women will answer electronic questionaires at inclusion and postpartum
Measured: up to 12 days after delivery
Secondary outcomes (2)
Labor outcomes
Hours from start induction and start active labor
Measured: From 1 hour to average of 48 hours
Cost per delivery
We will calculate the differences of costs and effects of one or more alternatives, and present the differences in the form of a ratio (ICER), i.e. the cost per unit of health outcome or effect. We will calculate cost-effectiveness (δ costs / δ effects) to evaluate whether outpatient induction shows to be dominant strategy regarding patient satisfaction.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start1 Jan 2022
- Primary completion29 Mar 2023
- Study completion29 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Induction of LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All eligible women will be recruited form a midwife and/or doctor. After the inclusion the women will be randomized to either inpatient or outpatient setting.
- Masking
- None (open label)
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Collaborators
- Haukeland University Hospital, St. Olavs Hospital, Nordlandssykehuset HF, Ostfold Hospital Trust
- Responsible party
- Sponsor
- Investigators
- Janne Rossen, MD, PhD, Principal investigator, Sorlandet HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05144048
- Sponsor's protocol ID
- 261787/2021
- Status last verified
- Sep 2022
- First submitted
- 3 Nov 2021
- Last updated
- 24 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
WHO recommendations: Induction of labour at or beyond term. Geneva: World Health Organization; 2018. Available from http://www.ncbi.nlm.nih.gov/books/NBK535795/
PubMed 30629393Alfirevic Z, Gyte GM, Nogueira Pileggi V, Plachcinski R, Osoti AO, Finucane EM. Home versus inpatient induction of labour for improving birth outcomes. Cochrane Database Syst Rev. 2020 Aug 27;8(8):CD007372. doi: 10.1002/14651858.CD007372.pub4.
PubMed 32852803Alfirevic Z, Aflaifel N, Weeks A. Oral misoprostol for induction of labour. Cochrane Database Syst Rev. 2014 Jun 13;2014(6):CD001338. doi: 10.1002/14651858.CD001338.pub3.
PubMed 24924489McDonagh M, Skelly AC, Tilden E, Brodt ED, Dana T, Hart E, Kantner SN, Fu R, Hermesch AC. Outpatient Cervical Ripening: A Systematic Review and Meta-analysis. Obstet Gynecol. 2021 Jun 1;137(6):1091-1101. doi: 10.1097/AOG.0000000000004382.
PubMed 33752219Helmig RB, Hvidman LE. An audit of oral administration of Angusta(R) (misoprostol) 25 microg for induction of labor in 976 consecutive women with a singleton pregnancy in a university hospital in Denmark. Acta Obstet Gynecol Scand. 2020 Oct;99(10):1396-1402. doi: 10.1111/aogs.13876. Epub 2020 May 19.
PubMed 32311758Ten Eikelder ML, Oude Rengerink K, Jozwiak M, de Leeuw JW, de Graaf IM, van Pampus MG, Holswilder M, Oudijk MA, van Baaren GJ, Pernet PJ, Bax C, van Unnik GA, Martens G, Porath M, van Vliet H, Rijnders RJ, Feitsma AH, Roumen FJ, van Loon AJ, Versendaal H, Weinans MJ, Woiski M, van Beek E, Hermsen B, Mol BW, Bloemenkamp KW. Induction of labour at term with oral misoprostol versus a Foley catheter (PROBAAT-II): a multicentre randomised controlled non-inferiority trial. Lancet. 2016 Apr 16;387(10028):1619-28. doi: 10.1016/S0140-6736(16)00084-2. Epub 2016 Feb 3.
PubMed 26850983Austad FE, Kessler J, Magnussen EB, Pripp AH, Rossen J. Outpatient Versus Inpatient Induction of Labour With Oral Misoprostol: A Multicentre Randomised-Controlled Trial. BJOG. 2025 Oct;132(11):1562-1573. doi: 10.1111/1471-0528.18296. Epub 2025 Jul 24.
PubMed 40704452
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Induction of Labor With Oral Misoprostol: A Multicenter Randomized-controlled Trial
- ClinicalTrials.gov ID
- NCT05144048
- Acronym / sponsor ID
- 261787/2021
- Conditions
- Induction of Labor
- Keywords
- induction, outpatient, misoprostol, childbirth experience
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Sorlandet Hospital HFOther government
- Collaborators
- Haukeland University Hospital, St. Olavs Hospital, Nordlandssykehuset HF, Ostfold Hospital Trust
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 29 Mar 2023 (actual)
- Study completion
- 29 Apr 2023 (actual)
- First posted
- 3 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Induction of labor is an increasingly used intervention in obstetrics due to expanding indications, which more often includes relatively healthy women with uncomplicated pregnancies. While induction of labor traditionally is offered in an inpatient setting, a shift towards an outpatient setting is increasing despite insufficient evidence regarding safety and effectiveness. Oral misoprostol is easy for the pregnant women to administer and the risk of uterine hyperstimulation with fetal heart rate changes is found to be low. Strong evidence concludes that oral misoprostol is preferable as an induction agent and is recommended by the World Health Organization (WHO).
The investigators will perform a multicenter randomized-controlled trial comparing labor induction in an outpatient versus inpatient setting, aiming to increase knowledge on outpatient induction of labor with oral misoprostol. The study is based on experiences and findings from a recently performed pilot trial and targets a large group of relatively healthy pregnant women where induction of labor is decided.
The investigators hypothesize that women induced in an outpatient setting will be more satisfied than women induced in an inpatient setting.
Detailed description
After induction of labor is decided the women will be recruited according to inclusion and exclusion criteria's.
The inpatient induction group will receive the following treatment:
Oral misoprostol 25ug every two hours and a cardiotocography for fetal monitoring every 4-6 hours until start of contractions, the next 48 hours while admitted to the maternity ward. The participating women will be transferred to the labor ward by start of contractions or need for closer fetal surveillance and/or analgesia.
The outpatient induction group will receive the following treatment:
These participating women receive the first oral misoprostol 25ug at the maternity unit. After two hours if the cardiotocograph is normal and there are no signs of contractions, these women go home. At home, the women will continue to take 25ug misoprostol every two hours until 22 pm or until the contractions begin. Maximum time spent at home is 48 hours and maximum number of tablets is 12 during this period (6 tablets each day). The women will also receive oral and written information regarding when to return to the maternity ward. Information sheets for the midwives and included women will be adapted from those used in the pilot study.
If the contractions are still absent after 48 hours or a maximum of 12 tablets (6 per day), all women (both inpatient and outpatient) are admitted to the maternity ward for further induction of labor. All women will receive equal standard of care including fetal surveillance after admittance to the hospital. Further follow up is in accordance with standard procedure of the maternity ward. Questions about fidelity to the proposed protocol across sites will be asked in the patient questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All eligible women will be recruited form a midwife and/or doctor. After the inclusion the women will be randomized to either inpatient or outpatient setting.
| Arm | Type | Receives |
|---|---|---|
| Induction of labour with oral misoprostol, inpatient setting | Active comparator | Other: Inpatient settingThese women receive all treatment in the maternity unit. |
| Induction of labour with oral misoprostol, outpatient setting | Experimental | Other: Outpatient settingThese women are observed 2 hours after they receive one dose of oral misoprostol before they leave the maternity unit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- ≥ 37 gestational weeks, vertex presentation, single pregnancy
- Age ≥ 18 years
- Understand and read Norwegian
- Distance to hospital less than 1 hour
- Normal ultrasound including:
Key exclusion criteria (11 listed)
- Premature rupture of membranes
- Uterine scar
- BMI ≥ 40
- Abnormal fetal Doppler (if examined); umbilical artery pulsatility index ≥ 95 percentile and/or cerebroplacental ratio <1
- Fetal anomaly or chromosomic / genetic disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inpatient settingThese women stay at the maternity unit | Other | Induction of labour with oral misoprostol, inpatient setting |
| Outpatient settingThese women leave the maternity unit | Other | Induction of labour with oral misoprostol, outpatient setting |
Primary outcome
Maternal childbirth experience and maternal experience with induction of labor
Time frame: up to 12 days after delivery
The women will answer electronic questionaires at inclusion and postpartum
2 secondary outcomes
Labor outcomes
Time frame: From 1 hour to average of 48 hours
Cost per delivery
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- Background: PubMed 30629393WHO recommendations: Induction of labour at or beyond term. Geneva: World Health Organization; 2018. Available from http://www.ncbi.nlm.nih.gov/books/NBK535795/
- Background: PubMed 32852803Alfirevic Z, Gyte GM, Nogueira Pileggi V, Plachcinski R, Osoti AO, Finucane EM. Home versus inpatient induction of labour for improving birth outcomes. Cochrane Database Syst Rev. 2020 Aug 27;8(8):CD007372. doi: 10.1002/14651858.CD007372.pub4.
- Background: PubMed 24924489Alfirevic Z, Aflaifel N, Weeks A. Oral misoprostol for induction of labour. Cochrane Database Syst Rev. 2014 Jun 13;2014(6):CD001338. doi: 10.1002/14651858.CD001338.pub3.
- Background: PubMed 33752219McDonagh M, Skelly AC, Tilden E, Brodt ED, Dana T, Hart E, Kantner SN, Fu R, Hermesch AC. Outpatient Cervical Ripening: A Systematic Review and Meta-analysis. Obstet Gynecol. 2021 Jun 1;137(6):1091-1101. doi: 10.1097/AOG.0000000000004382.
- Background: PubMed 32311758Helmig RB, Hvidman LE. An audit of oral administration of Angusta(R) (misoprostol) 25 microg for induction of labor in 976 consecutive women with a singleton pregnancy in a university hospital in Denmark. Acta Obstet Gynecol Scand. 2020 Oct;99(10):1396-1402. doi: 10.1111/aogs.13876. Epub 2020 May 19.
- Background: PubMed 26850983Ten Eikelder ML, Oude Rengerink K, Jozwiak M, de Leeuw JW, de Graaf IM, van Pampus MG, Holswilder M, Oudijk MA, van Baaren GJ, Pernet PJ, Bax C, van Unnik GA, Martens G, Porath M, van Vliet H, Rijnders RJ, Feitsma AH, Roumen FJ, van Loon AJ, Versendaal H, Weinans MJ, Woiski M, van Beek E, Hermsen B, Mol BW, Bloemenkamp KW. Induction of labour at term with oral misoprostol versus a Foley catheter (PROBAAT-II): a multicentre randomised controlled non-inferiority trial. Lancet. 2016 Apr 16;387(10028):1619-28. doi: 10.1016/S0140-6736(16)00084-2. Epub 2016 Feb 3.
- Derived from this study: PubMed 40704452Austad FE, Kessler J, Magnussen EB, Pripp AH, Rossen J. Outpatient Versus Inpatient Induction of Labour With Oral Misoprostol: A Multicentre Randomised-Controlled Trial. BJOG. 2025 Oct;132(11):1562-1573. doi: 10.1111/1471-0528.18296. Epub 2025 Jul 24.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janne Rossen, MD, PhD principal investigator
Sorlandet HF
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inpatient setting and Outpatient setting in people with Induction of Labor, run by Sorlandet Hospital HF at 5 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal childbirth experience and maternal experience with induction of labor (time frame: up to 12 days after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05144048, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2023.