Labor InductionNCT04596397
Oral Misoprostol for Outpatient Induction of Labor
A study testing Inpatient setting and Outpatient setting in people with Labor Induction, run by Sorlandet Hospital HF at 1 site in Norway.
Trial summary
An increasing proportion of pregnant women have their labors induced due to changing guidelines. In correlation with this increase, the population of the induced women has changed toward more women with a low-risk pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Labor Induction
- 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
- 20 participants
- Where
- 1 siteNorway
- Study dates
- 16 Nov 2020to 25 Mar 2021
- 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 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Understand and read Norwegian
- No cognitive barriers. The woman must be able to give informed consent
- ≥ 37 gestational week, vertex presentation, single pregnancy
- Normal ultrasound including fetal movements, amniotic fluid, estimated fetal weight +/- 15% (≤ 10 percentile and ≥ 90) and normal doppler peak systolic index in the umbilical cord artery and the cerebri media artery
- Normal cardiotocography
- Body Mass Index 18-35
- No signs of infection or health problems
- Distance to hospital 45-60 minutes
Who cannot join
- Premature rupture of membranes
- Previous cesarean section or operation on uterus
- Fetal anomaly or chromosome/genetic disorder
- Pregnancy complications such as preeclampsia and diabetes (insulin dependent) or other conditions were changes in fetal heart rate during labor is suspected
- Not eligible for misoprostol as induction agent due a favorable cervix (Bishop score) and/or previous obstetric history
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Misoprostol for Outpatient Induction of Labor; a Pilot Randomized-controlled Trial
An increasing proportion of pregnant women have their labors induced due to changing guidelines. In correlation with this increase, the population of the induced women has changed toward more women with a low-risk pregnancy. Traditionally, induction of labor has taken place in an inpatient setting where the women have spent extra days in hospital before delivery.
Oral prostaglandins, such as misoprostol, is one of the most commonly used induction agent and is easy for the pregnant women to administrate. The pharmacological effect is ripening the cervix and compared to the mechanical cervical ripening, with a balloon catheter, the demands on busy maternity services seems reduced. Before contractions start, the risk of adverse effects on mother or fetus is considered low, but the evidence on use of misoprostol in an outpatient setting is sparse.
Read the detailed description
The implementation of induction of labor in outpatient settings is increasing despite insufficient evidence regarding safety and effectiveness. The use of a balloon catheter in an outpatient setting is not associated with adverse outcomes in a low-risk population. There is also evidence that outpatient vs inpatient induction of labor with balloon catheter is equally effective. Examination of vaginal dinoprostone (prostaglandin E2) is found to be efficacious in outpatient settings. However, strong evidence concludes that the oral route of administration of prostaglandin is preferable when inducing labor. The World Health Organization recommend 25ug misoprostol (prostaglandin E1) orally every 2 hour until contractions start for induction of labor.
The women randomized to an inpatient setting will receive the hospital standard follow-up; oral misoprostol 25ug every two hours and a cardiotocography for fetal monitoring every 4-6 hour until start of contractions for two days.
The women randomized to an outpatient setting will receive one oral misoprostol 25ug at the maternity unit. After two hours, provided a normal cardiotocography and no contractions, they can go home. They will continue to take 25ug misoprostol every two hours until start of contractions or increasing pain. Maximum time spent at home will be 48 hours.
A dedicated midwife on call will always be available for questions. The women will receive oral and written information to return to the maternity unit if the water breaks, if they experience increasing pain or bleeding, if they feel insecure or anxious, if there are reduced or no fetal movements, and/or when the contraction starts. When the woman returns, she will stay admitted until delivery.
All women will be given standard of care and fetal surveillance when admitted to the hospital, when the contractions start or if the contractions are still absent after 48 hours. We will also ask eligible women who refrain to participate about their reasons for non-participation.
PRIMARY RESEARCH QUESTION We aim to explore that induction of labor using oral misoprostol appears feasible in an outpatient setting and may positively influence the length of the hospital stay and maternal satisfaction.
PRIMARY RESEARCH PLAN This is a pilot study to explore the feasibility of a possible multicenter randomized controlled trail.
- Conditions
- Labor Induction
- Being tested
- Inpatient setting, Outpatient setting
- Keywords
- induction of labor, outpatient setting, misoprostol
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 hospital.
Outpatient settingOther
These women can leave the hospital.
| 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 will be observed 2 hours after they receive one dose of oral misoprostol before the can 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.
The feasibility of a randomised controlled trial of outpatient labor induction
The number of eligible women who is willing to enrol in participating
Measured: 6 months
Secondary outcomes (3)
Reported labor experience among the women participating
The women will fill out a survey before and after birth (including childbirth expectations, experience and satisfaction)
Measured: From included in the study until postpartum discharge (1-2 weeks)
Maternal length of hospital stay
Length of hospital stay form start of induction to postpartum discharge
Measured: From included in the study until postpartum discharge (1-2 weeks)
Use of analgesia
Use of epidural and fentanyl analgesia during labor
Measured: From start of the partogram until birth (hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start16 Nov 2020
- Primary completion15 Mar 2021
- Study completion25 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Labor InductionStudies 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 they will be randomized to either inpatient or outpatient setting.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Janne Rossen, MD, PhD, Principal investigator, Sorlandet Hospital Trust, Kristiansand, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04596397
- Sponsor's protocol ID
- 2020/104044
- Status last verified
- Apr 2021
- First submitted
- 12 Oct 2020
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vogel JP, Osoti AO, Kelly AJ, Livio S, Norman JE, Alfirevic Z. Pharmacological and mechanical interventions for labour induction in outpatient settings. Cochrane Database Syst Rev. 2017 Sep 13;9(9):CD007701. doi: 10.1002/14651858.CD007701.pub3.
PubMed 28901007Alfirevic 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 24924489WHO Recommendations for Induction of Labour. Geneva: World Health Organization; 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK131963/
PubMed 23586118Diederen M, Gommers J, Wilkinson C, Turnbull D, Mol B. Safety of the balloon catheter for cervical ripening in outpatient care: complications during the period from insertion to expulsion of a balloon catheter in the process of labour induction: a systematic review. BJOG. 2018 Aug;125(9):1086-1095. doi: 10.1111/1471-0528.15047. Epub 2018 Jan 10.
PubMed 29211328Wilkinson C, Bryce R, Adelson P, Turnbull D. A randomised controlled trial of outpatient compared with inpatient cervical ripening with prostaglandin E(2) (OPRA study). BJOG. 2015 Jan;122(1):94-104. doi: 10.1111/1471-0528.12846. Epub 2014 May 14.
PubMed 24824157
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Misoprostol for Outpatient Induction of Labor; a Pilot Randomized-controlled Trial
- ClinicalTrials.gov ID
- NCT04596397
- Acronym / sponsor ID
- 2020/104044
- Conditions
- Labor Induction
- Keywords
- induction of labor, outpatient setting, misoprostol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sorlandet Hospital HFOther government
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 25 Mar 2021 (actual)
- First posted
- 22 Oct 2020 (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.
An increasing proportion of pregnant women have their labors induced due to changing guidelines. In correlation with this increase, the population of the induced women has changed toward more women with a low-risk pregnancy. Traditionally, induction of labor has taken place in an inpatient setting where the women have spent extra days in hospital before delivery.
Oral prostaglandins, such as misoprostol, is one of the most commonly used induction agent and is easy for the pregnant women to administrate. The pharmacological effect is ripening the cervix and compared to the mechanical cervical ripening, with a balloon catheter, the demands on busy maternity services seems reduced. Before contractions start, the risk of adverse effects on mother or fetus is considered low, but the evidence on use of misoprostol in an outpatient setting is sparse.
Detailed description
The implementation of induction of labor in outpatient settings is increasing despite insufficient evidence regarding safety and effectiveness. The use of a balloon catheter in an outpatient setting is not associated with adverse outcomes in a low-risk population. There is also evidence that outpatient vs inpatient induction of labor with balloon catheter is equally effective. Examination of vaginal dinoprostone (prostaglandin E2) is found to be efficacious in outpatient settings. However, strong evidence concludes that the oral route of administration of prostaglandin is preferable when inducing labor. The World Health Organization recommend 25ug misoprostol (prostaglandin E1) orally every 2 hour until contractions start for induction of labor.
The women randomized to an inpatient setting will receive the hospital standard follow-up; oral misoprostol 25ug every two hours and a cardiotocography for fetal monitoring every 4-6 hour until start of contractions for two days.
The women randomized to an outpatient setting will receive one oral misoprostol 25ug at the maternity unit. After two hours, provided a normal cardiotocography and no contractions, they can go home. They will continue to take 25ug misoprostol every two hours until start of contractions or increasing pain. Maximum time spent at home will be 48 hours.
A dedicated midwife on call will always be available for questions. The women will receive oral and written information to return to the maternity unit if the water breaks, if they experience increasing pain or bleeding, if they feel insecure or anxious, if there are reduced or no fetal movements, and/or when the contraction starts. When the woman returns, she will stay admitted until delivery.
All women will be given standard of care and fetal surveillance when admitted to the hospital, when the contractions start or if the contractions are still absent after 48 hours. We will also ask eligible women who refrain to participate about their reasons for non-participation.
PRIMARY RESEARCH QUESTION We aim to explore that induction of labor using oral misoprostol appears feasible in an outpatient setting and may positively influence the length of the hospital stay and maternal satisfaction.
PRIMARY RESEARCH PLAN This is a pilot study to explore the feasibility of a possible multicenter randomized controlled trail.
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 they 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 will be observed 2 hours after they receive one dose of oral misoprostol before the can leave the maternity unit. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Understand and read Norwegian
- No cognitive barriers. The woman must be able to give informed consent
- ≥ 37 gestational week, vertex presentation, single pregnancy
- Normal ultrasound including fetal movements, amniotic fluid, estimated fetal weight +/- 15% (≤ 10 percentile and ≥ 90) and normal doppler peak systolic index in the umbilical cord artery and the cerebri media artery
- Normal cardiotocography
Key exclusion criteria (5 listed)
- Premature rupture of membranes
- Previous cesarean section or operation on uterus
- Fetal anomaly or chromosome/genetic disorder
- Pregnancy complications such as preeclampsia and diabetes (insulin dependent) or other conditions were changes in fetal heart rate during labor is suspected
- Not eligible for misoprostol as induction agent due a favorable cervix (Bishop score) and/or previous obstetric history
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 hospital. | Other | Induction of labour with oral misoprostol, inpatient setting |
| Outpatient settingThese women can leave the hospital. | Other | Induction of labour with oral misoprostol, outpatient setting |
Primary outcome
The feasibility of a randomised controlled trial of outpatient labor induction
Time frame: 6 months
The number of eligible women who is willing to enrol in participating
3 secondary outcomes
Reported labor experience among the women participating
Time frame: From included in the study until postpartum discharge (1-2 weeks)
Maternal length of hospital stay
Time frame: From included in the study until postpartum discharge (1-2 weeks)
Use of analgesia
Time frame: From start of the partogram until birth (hours)
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 19 Apr 2021.
- Background: PubMed 28901007Vogel JP, Osoti AO, Kelly AJ, Livio S, Norman JE, Alfirevic Z. Pharmacological and mechanical interventions for labour induction in outpatient settings. Cochrane Database Syst Rev. 2017 Sep 13;9(9):CD007701. doi: 10.1002/14651858.CD007701.pub3.
- 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 23586118WHO Recommendations for Induction of Labour. Geneva: World Health Organization; 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK131963/
- Background: PubMed 29211328Diederen M, Gommers J, Wilkinson C, Turnbull D, Mol B. Safety of the balloon catheter for cervical ripening in outpatient care: complications during the period from insertion to expulsion of a balloon catheter in the process of labour induction: a systematic review. BJOG. 2018 Aug;125(9):1086-1095. doi: 10.1111/1471-0528.15047. Epub 2018 Jan 10.
- Background: PubMed 24824157Wilkinson C, Bryce R, Adelson P, Turnbull D. A randomised controlled trial of outpatient compared with inpatient cervical ripening with prostaglandin E(2) (OPRA study). BJOG. 2015 Jan;122(1):94-104. doi: 10.1111/1471-0528.12846. Epub 2014 May 14.
- 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 Hospital Trust, Kristiansand, Norway
1 site 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 Labor Induction, run by Sorlandet Hospital HF at 1 site 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 8 inclusion and 5 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 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The feasibility of a randomised controlled trial of outpatient labor induction (time frame: 6 months). 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 NCT04596397, which also lists 5 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 19 Apr 2021.