Pre-eclampsiaPhase 3INFORMNCT01801410
Induction With Foley OR Misoprostol (INFORM) Study
A Phase 3 study testing Foley Catheter and Misoprostol in people with Pre-eclampsia and Fetus or Newborn; Effects of Induction of Labor, run by University of Liverpool at 2 sites in India.
Trial summary
Between 40,000 and 80,000 pregnant women die annually from pre-eclampsia and eclampsia. Magnesium sulphate and anti-hypertensive therapies can reduce the morbidity associated with pre-eclampsia. The only cure, however, comes with delivery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pre-eclampsia, Fetus or Newborn; Effects of Induction of Labor
- What is being tested?
- Foley Catheter and Misoprostol
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 602 participants
- Where
- 2 sitesIndia
- Study dates
- Dec 2013to Jun 2015
- Phase
- Phase 3
- 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
- Ongoing pregnancies with a live fetus in whom the decision has been made to induce vaginal delivery because of preeclampsia or uncontrolled hypertension. Women will be included irrespective of whether an intrapartum caesarean section on fetal grounds or would be considered or not.
- Women age ≥18 years
- Signed informed consent form
Who cannot join
- • Women with previous caesarean sections
- Those unable to give informed consent
- Multiple pregnancy
- History of allergy to misoprostol
- Ruptured membranes
- Chorioamnionitis (by clinical diagnosis)
Trial locations and contacts
2 sites in 1 country.
India2 sites
Daga Memorial Women's Hospital
Nagpur, Maharashtra
Government Medical College (GMC)
Nagpur
About this study
Official title: Induction of Labour in Pre-eclamptic Women: a Randomised Trial Comparing the Foley Balloon Catheter With Oral Misoprostol
Between 40,000 and 80,000 pregnant women die annually from pre-eclampsia and eclampsia. Magnesium sulphate and anti-hypertensive therapies can reduce the morbidity associated with pre-eclampsia. The only cure, however, comes with delivery. Prompt delivery of the baby, preferably by vaginal route, is vital in order to achieve good maternal and neonatal outcomes. Induction of labour is therefore a critical intervention in order to prevent morbidity to both mother and baby. Two low cost interventions - oral misoprostol tablets and transcervical Foley catheterization - are already used by some in low resource settings, but their relative risks and benefits are not known. These interventions could optimize the care pathway for women needing induction of labour. This is especially important in low resource settings where improvement is most needed and the potential to reduce the maternal and neonatal mortality and morbidity is the greatest. The ideal induction agent would result in a relatively short induction to delivery interval without risk to fetus and with low rates of emergency caesarean section. The induction to delivery interval is especially important in pre-eclampsia and eclampsia where the condition may deteriorate rapidly until delivery. Inductions with prostaglandins, including misoprostol, are sometimes associated with uterine hyperstimulation and consequent fetal hypoxia, whilst the effectiveness and safety of Foley catheter as an induction agent has been persistently questioned. This study will identify the risk, benefits and trade-offs in efficacy, safety, acceptability and cost of these two low cost induction methods.
Read the detailed description
This is a pragmatic, open-label, randomised control trial of two methods for labour induction among women with pre-eclampsia. Women requiring delivery for preeclampsia in two hospitals in Nagpur, India will be randomised to one of two treatment groups: transcervical Foley catheter or oral misoprostol tablets.
- Being tested
- Foley Catheter, Misoprostol
- Keywords
- pre-eclampsia, labor induction, misoprostol, Foley catheter
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foley CatheterDevice
Also called Cervical ripening balloon, balloon catheter
Transcervical Foley catheter (silicone, size 18F with 30ml balloon)
MisoprostolDrug
Also called Cytotec
25mcg every 2 hours for maximum of 12 doses
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol | Active comparator | Group 2 will be induced using oral misoprostol tablets (25 mcg) every 2 hours for a maximum of 12 doses or until active labour commences. In primigravid women, if contractions have not commenced after 2 doses, the dosage may be increased to 50mcg every 2 hours. Once in labour (regular painful contractions with a cervical dilatation of at least 4cm) no more misoprostol will be used and artificial membrane rupture and/or oxytocin infusion will be used as clinically indicated. If labour has still not commenced after 24 hours, they will be deemed to have a 'failed induction' and the decision on further management will be made by the clinical team (their choice could include the use of repeat misoprostol, Foley catheter, dinoprostone, caesarean section or delay as deemed appropriate). Receives: Drug: Misoprostol |
| Foley Catheter | Active comparator | Group 1 will undergo induction using a transcervical Foley catheter (silicone, size 18F with 30ml balloon) which will remain until active labour starts, the Foley catheter falls out, or 12 hours have elapsed. If the Foley catheter falls out within 12h, membranes will be ruptured and/or oxytocin infusion started. If the Foley catheter does not fall out within 12h, it will be removed at 12h and oxytocin commenced with an artificial rupture of membrane when possible. If labour has still not commenced after 24 hours, they will be deemed to have a 'failed induction' and the decision on further management will be made by the clinical team (their choice could include the use of misoprostol, repeat Foley catheter, dinoprostone, caesarean section or delay as deemed appropriate). Receives: Device: Foley Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attainment of vaginal delivery within 24 hours.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2013 (estimated)
- Study startDec 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pre-eclampsiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 602 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liverpool
- Sponsor type
- University, hospital or other
- Collaborators
- Gynuity Health Projects, Government Dental College and Hospital, India, Daga Memorial Women's Hospital, Nagpur, India
- Responsible party
- Principal investigator, Andrew Weeks MD MRCOG, University of Liverpool
- Investigators
- Andrew D Weeks, MD FRCOG, Principal investigator, University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01801410
- Sponsor's protocol ID
- 4001
- Acronym
- INFORM
- Status last verified
- Dec 2015
- First submitted
- 14 Feb 2013
- Last updated
- 14 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mundle S, Bracken H, Khedikar V, Mulik J, Faragher B, Easterling T, Leigh S, Granby P, Haycox A, Turner MA, Alfirevic Z, Winikoff B, Weeks AD. Foley catheterisation versus oral misoprostol for induction of labour in hypertensive women in India (INFORM): a multicentre, open-label, randomised controlled trial. Lancet. 2017 Aug 12;390(10095):669-680. doi: 10.1016/S0140-6736(17)31367-3. Epub 2017 Jun 28.
PubMed 28668289Bracken H, Mundle S, Faragher B, Easterling T, Haycox A, Turner M, Alfirevic Z, Winikoff B, Weeks A. Induction of labour in pre-eclamptic women: a randomised trial comparing the Foley balloon catheter with oral misoprostol. BMC Pregnancy Childbirth. 2014 Sep 5;14:308. doi: 10.1186/1471-2393-14-308.
PubMed 25193157
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction of Labour in Pre-eclamptic Women: a Randomised Trial Comparing the Foley Balloon Catheter With Oral Misoprostol
- ClinicalTrials.gov ID
- NCT01801410
- Acronym / sponsor ID
- INFORM / 4001
- Keywords
- pre-eclampsia, labor induction, misoprostol, Foley catheter
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 602 participants (actual)
- Lead sponsor
- University of LiverpoolUniversity, hospital or other
- Collaborators
- Gynuity Health Projects, Government Dental College and Hospital, India, Daga Memorial Women's Hospital, Nagpur, India
- Study start
- Dec 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 28 Feb 2013 (estimated)
- 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.
Between 40,000 and 80,000 pregnant women die annually from pre-eclampsia and eclampsia. Magnesium sulphate and anti-hypertensive therapies can reduce the morbidity associated with pre-eclampsia. The only cure, however, comes with delivery. Prompt delivery of the baby, preferably by vaginal route, is vital in order to achieve good maternal and neonatal outcomes. Induction of labour is therefore a critical intervention in order to prevent morbidity to both mother and baby. Two low cost interventions - oral misoprostol tablets and transcervical Foley catheterization - are already used by some in low resource settings, but their relative risks and benefits are not known. These interventions could optimize the care pathway for women needing induction of labour. This is especially important in low resource settings where improvement is most needed and the potential to reduce the maternal and neonatal mortality and morbidity is the greatest. The ideal induction agent would result in a relatively short induction to delivery interval without risk to fetus and with low rates of emergency caesarean section. The induction to delivery interval is especially important in pre-eclampsia and eclampsia where the condition may deteriorate rapidly until delivery. Inductions with prostaglandins, including misoprostol, are sometimes associated with uterine hyperstimulation and consequent fetal hypoxia, whilst the effectiveness and safety of Foley catheter as an induction agent has been persistently questioned. This study will identify the risk, benefits and trade-offs in efficacy, safety, acceptability and cost of these two low cost induction methods.
Detailed description
This is a pragmatic, open-label, randomised control trial of two methods for labour induction among women with pre-eclampsia. Women requiring delivery for preeclampsia in two hospitals in Nagpur, India will be randomised to one of two treatment groups: transcervical Foley catheter or oral misoprostol tablets.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Misoprostol | Active comparator | Drug: MisoprostolGroup 2 will be induced using oral misoprostol tablets (25 mcg) every 2 hours for a maximum of 12 doses or until active labour commences. In primigravid women, if contractions have not commenced after 2 doses, the dosage may be increased to 50mcg every 2 hours. Once in labour (regular painful contractions with a cervical dilatation of at least 4cm) no more misoprostol will be used and artificial membrane rupture and/or oxytocin infusion will be used as clinically indicated. If labour has still not commenced after 24 hours, they will be deemed to have a 'failed induction' and the decision on further management will be made by the clinical team (their choice could include the use of repeat misoprostol, Foley catheter, dinoprostone, caesarean section or delay as deemed appropriate). |
| Foley Catheter | Active comparator | Device: Foley CatheterGroup 1 will undergo induction using a transcervical Foley catheter (silicone, size 18F with 30ml balloon) which will remain until active labour starts, the Foley catheter falls out, or 12 hours have elapsed. If the Foley catheter falls out within 12h, membranes will be ruptured and/or oxytocin infusion started. If the Foley catheter does not fall out within 12h, it will be removed at 12h and oxytocin commenced with an artificial rupture of membrane when possible. If labour has still not commenced after 24 hours, they will be deemed to have a 'failed induction' and the decision on further management will be made by the clinical team (their choice could include the use of misoprostol, repeat Foley catheter, dinoprostone, caesarean section or delay as deemed appropriate). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ongoing pregnancies with a live fetus in whom the decision has been made to induce vaginal delivery because of preeclampsia or uncontrolled hypertension. Women will be included irrespective of whether an intrapartum caesarean section on fetal grounds or would be considered or not.
- Women age ≥18 years
- Signed informed consent form
Key exclusion criteria (6 listed)
- • Women with previous caesarean sections
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 |
|---|---|---|
| Foley CatheterAlso: Cervical ripening balloon, balloon catheterTranscervical Foley catheter (silicone, size 18F with 30ml balloon) | Device | Foley Catheter |
| MisoprostolAlso: Cytotec25mcg every 2 hours for maximum of 12 doses | Drug | Misoprostol |
Primary outcome
Attainment of vaginal delivery within 24 hours.
Time frame: 24 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 14 Dec 2015.
- Derived from this study: PubMed 28668289Mundle S, Bracken H, Khedikar V, Mulik J, Faragher B, Easterling T, Leigh S, Granby P, Haycox A, Turner MA, Alfirevic Z, Winikoff B, Weeks AD. Foley catheterisation versus oral misoprostol for induction of labour in hypertensive women in India (INFORM): a multicentre, open-label, randomised controlled trial. Lancet. 2017 Aug 12;390(10095):669-680. doi: 10.1016/S0140-6736(17)31367-3. Epub 2017 Jun 28.
- Derived from this study: PubMed 25193157Bracken H, Mundle S, Faragher B, Easterling T, Haycox A, Turner M, Alfirevic Z, Winikoff B, Weeks A. Induction of labour in pre-eclamptic women: a randomised trial comparing the Foley balloon catheter with oral misoprostol. BMC Pregnancy Childbirth. 2014 Sep 5;14:308. doi: 10.1186/1471-2393-14-308.
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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.
Andrew D Weeks, MD FRCOG principal investigator
University of Liverpool
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Foley Catheter and Misoprostol in people with Pre-eclampsia and Fetus or Newborn; Effects of Induction of Labor, run by University of Liverpool at 2 sites in India.
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 3 inclusion and 6 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 14 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Attainment of vaginal delivery within 24 hours. (time frame: 24 hours). 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 NCT01801410, which also lists 2 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 14 Dec 2015; AzTrials last refreshed its copy on 28 Oct 2026.