Labor; Forced or Induced, Affecting Fetus or NewbornNCT04271722

Clinical Evaluation of Cervical Ripening in the Outpatient Setting

A study testing Cervical ripening in people with Labor; Forced or Induced, Affecting Fetus or Newborn and Labor Onset and Length Abnormalities, run by Centro Hospitalar Lisboa Norte at 1 site in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A randomized controlled trial of mifepristone 200mg vs balloon catheter for cervical ripening. Read more about this study

Who is it for?: Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Labor; Forced or Induced, Affecting Fetus or Newborn, Labor Onset and Length Abnormalities
What is being tested?: Cervical ripening
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 101 participants
Where: 1 sitePortugal
Study dates: 15 Jan 2020to 30 Dec 2022
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 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Pregnant woman scheduled for induction of labor.
Age between 18 and 45 years.
Understanding and capable to sign informed consent.
Singleton pregnancy.
Gestational age ≥ 37 0/7 weeks.
Live fetus in cephalic presentation.

Show all 11Show fewer

Intact membranes
Bishop score < 6
Estimated fetal weight < 4500g
Without contraindication to vaginal delivery
No major fetal anomaly

Who cannot join

Previous cesarean section or myomectomy
Hypertension
Diabetes
Thyroid disease
Maternal conditions with high risk of placental insufficiency

Trial locations and contacts

1 site in 1 country.

Portugal1 site

Centro Hospitalar Lisboa Norte
Lisbon

Other trials in Portugal

About this study

Official title: Clinical Evaluation of Cervical Ripening in the Outpatient Setting Using Mifepristone Versus Balloon Catheter: a Randomized Controlled Trial

A randomized controlled trial of mifepristone 200mg vs balloon catheter for cervical ripening.

Read the detailed description

Artificial induction of labour is currently required in 25-30% of all pregnancies, in high-resource countries. While the pharmacological modifications to the collagen matrix of the cervix, that allow it to dilate (cervical ripening) occur spontaneously in many women, allowing labour to be induced with oxytocin, in others the process needs to be triggered artificially. Cervical ripening is traditionally accomplished with prostaglandins or mechanical agents, in processes that typically require 12-24 hours of hospital stay. More recently, a limited number of hospitals have shifted towards starting the process in house, but then allowing women to return home and be re-evaluated on the following day.

The main aims this study is to compare efficacy and patient satisfaction of mifepristone vs balloon catheter for cervical ripening.

Conditions: Labor; Forced or Induced, Affecting Fetus or Newborn, Labor Onset and Length Abnormalities
Being tested: Cervical ripening
Keywords: cervical ripening, mifepristone, balloon catheter

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cervical ripeningOther
Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.

Study groups in NCT04271722
Study group	Role	What they receive
Mifepristone	Experimental	Mifepristone 200mg 24hours before the induction day Receives: Other: Cervical ripening
Balloon catheter	Active comparator	Balloon catheter with 40ml placed 24hours before the induction day Receives: Other: Cervical ripening

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants with Bishop score ≥6 or spontaneous labour
Proportion of patients (%) with Bishop score ≥6 or spontaneous labour 24 hours after intervention
Measured: 24 hours

Secondary outcomes (13)

Mean of gain in Bishop score
Mean of gain in Bishop score from intervention to hospital admission
Measured: 24 hours
Time frame between intervention and active phase of labour
Time frame between intervention and active phase of labour (min)
Measured: 1-2 days
Time of Vaginal Delivery
Delivery time frame in mins from intervention
Measured: 2-4days
Number of Participants with vaginal delivery within 24hrs
Rate of vaginal deliveries within 24 hours since admission to hospital (%)
Measured: 1-2days
Vaginal delivery within 48hrs
Rate of vaginal deliveries within 48 hours since admission to hospital (%)
Measured: 1-2days
Pharmacological agents for labor induction (Prostaglandins, Oxytocin)
Rate of women that required pharmacological cervical ripening agents (%) requirement (%)
Measured: 1-2days
Operative deliveries
Proportion of patients that delivered vaginal by forceps assistance or vacuum (%) assistance.
Measured: 1-4days
Cesarean deliveries
Proportion of patients that delivered by cesarean (%).
Measured: 1-4days
Analgesia requirement
Rate of women who require any analgesia during cervical ripening process (%)
Measured: 24 hours
Vaginal bleeding
Rate of women who had vaginal bleeding during cervical ripening process (%)
Measured: 24 hours
Reduced fetal movements
Rate of women who had reduced fetal movements during cervical ripening process (%)
Measured: 24 hours
Non reassuring fetal status
Rate of women who had non reassuring fetal status(CTG) during cervical ripening process (%)
Measured: 24 hours
Patient Satisfaction: questionnaire
Patient satisfaction associated with intervention used for cervical ripening from patient questionnaire
Measured: 1-4days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jan 202030 Dec 2022

First posted17 Feb 2020
Study start15 Jan 2020
Primary completion30 Dec 2022
Study completion30 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Labor; Forced or Induced, Affecting Fetus or NewbornStudies 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
Masking: None (open label)
Enrolment: 101 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04271722
Sponsor's protocol ID: 2020OBST1
Status last verified: May 2024
First submitted: 13 Feb 2020
Last updated: 31 May 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Diederen 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 29211328
Heikinheimo O, Kekkonen R, Lahteenmaki P. The pharmacokinetics of mifepristone in humans reveal insights into differential mechanisms of antiprogestin action. Contraception. 2003 Dec;68(6):421-6. doi: 10.1016/s0010-7824(03)00077-5.
PubMed 14698071
Smith R, Smith JI, Shen X, Engel PJ, Bowman ME, McGrath SA, Bisits AM, McElduff P, Giles WB, Smith DW. Patterns of plasma corticotropin-releasing hormone, progesterone, estradiol, and estriol change and the onset of human labor. J Clin Endocrinol Metab. 2009 Jun;94(6):2066-74. doi: 10.1210/jc.2008-2257. Epub 2009 Mar 3.
PubMed 19258402
Ceccaldi PF, Saada J, Nicolas M, Ducarme G, Blot P, Guibourdenche J, Luton D. Modulation of free corticotrophin-releasing hormone, adrenal and placental steroid hormone levels induced by mifepristone during pregnancy. Fetal Diagn Ther. 2012;32(4):267-70. doi: 10.1159/000338927. Epub 2012 Jul 4.
PubMed 22759411
Rodger MW, Baird DT. Pretreatment with mifepristone (RU 486) reduces interval between prostaglandin administration and expulsion in second trimester abortion. Br J Obstet Gynaecol. 1990 Jan;97(1):41-5. doi: 10.1111/j.1471-0528.1990.tb01714.x.
PubMed 2407284
Urquhart DR, Bahzad C, Templeton AA. Efficacy of the antiprogestin mifepristone (RU 486) prior to prostaglandin termination of pregnancy. Hum Reprod. 1989 Feb;4(2):202-3. doi: 10.1093/oxfordjournals.humrep.a136872.
PubMed 2918074
Elliott CL, Brennand JE, Calder AA. The effects of mifepristone on cervical ripening and labor induction in primigravidae. Obstet Gynecol. 1998 Nov;92(5):804-9. doi: 10.1016/s0029-7844(98)00284-1.
PubMed 9794673
Yelikar K, Deshpande S, Deshpande R, Lone D. Safety and Efficacy of Oral Mifepristone in Pre-induction Cervical Ripening and Induction of Labour in Prolonged Pregnancy. J Obstet Gynaecol India. 2015 Jul;65(4):221-5. doi: 10.1007/s13224-014-0584-6. Epub 2014 Jul 11.
PubMed 26243986
Baev OR, Rumyantseva VP, Tysyachnyu OV, Kozlova OA, Sukhikh GT. Outcomes of mifepristone usage for cervical ripening and induction of labour in full-term pregnancy. Randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2017 Oct;217:144-149. doi: 10.1016/j.ejogrb.2017.08.038. Epub 2017 Sep 1.
PubMed 28898687
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 28901007

Study at a glance

From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of Cervical Ripening in the Outpatient Setting Using Mifepristone Versus Balloon Catheter: a Randomized Controlled Trial
ClinicalTrials.gov ID: NCT04271722
Acronym / sponsor ID: 2020OBST1
Conditions: Labor; Forced or Induced, Affecting Fetus or Newborn, Labor Onset and Length Abnormalities
Keywords: cervical ripening, mifepristone, balloon catheter
Study type: Interventional
Recruitment status: Completed
Enrolment: 101 participants (actual)
Lead sponsor: Centro Hospitalar Lisboa NorteUniversity, hospital or other
Study start: 15 Jan 2020 (actual)
Primary completion: 30 Dec 2022 (actual)
Study completion: 30 Dec 2022 (actual)
First posted: 17 Feb 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.

A randomized controlled trial of mifepristone 200mg vs balloon catheter for cervical ripening.

Detailed description

The main aims this study is to compare efficacy and patient satisfaction of mifepristone vs balloon catheter for cervical ripening.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Mifepristone	Experimental	Other: Cervical ripeningMifepristone 200mg 24hours before the induction day
Balloon catheter	Active comparator	Other: Cervical ripeningBalloon catheter with 40ml placed 24hours before the induction day

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (11 listed)

Pregnant woman scheduled for induction of labor.
Age between 18 and 45 years.
Understanding and capable to sign informed consent.
Singleton pregnancy.
Gestational age ≥ 37 0/7 weeks.

Key exclusion criteria (5 listed)

Previous cesarean section or myomectomy
Hypertension
Diabetes
Thyroid disease
Maternal conditions with high risk of placental insufficiency

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
Cervical ripeningSubjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.	Other	Balloon catheter, Mifepristone

Primary outcome

Number of Participants with Bishop score ≥6 or spontaneous labour
Time frame: 24 hours
Proportion of patients (%) with Bishop score ≥6 or spontaneous labour 24 hours after intervention

13 secondary outcomes

Mean of gain in Bishop score
Time frame: 24 hours
Time frame between intervention and active phase of labour
Time frame: 1-2 days
Time of Vaginal Delivery
Time frame: 2-4days
Number of Participants with vaginal delivery within 24hrs
Time frame: 1-2days
Vaginal delivery within 48hrs
Time frame: 1-2days
Pharmacological agents for labor induction (Prostaglandins, Oxytocin)
Time frame: 1-2days
Operative deliveries
Time frame: 1-4days
Cesarean deliveries
Time frame: 1-4days
Analgesia requirement
Time frame: 24 hours
Vaginal bleeding
Time frame: 24 hours
Reduced fetal movements
Time frame: 24 hours
Non reassuring fetal status
Time frame: 24 hours
Patient Satisfaction: questionnaire
Time frame: 1-4days

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 31 May 2024.
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 14698071Heikinheimo O, Kekkonen R, Lahteenmaki P. The pharmacokinetics of mifepristone in humans reveal insights into differential mechanisms of antiprogestin action. Contraception. 2003 Dec;68(6):421-6. doi: 10.1016/s0010-7824(03)00077-5.
Background: PubMed 19258402Smith R, Smith JI, Shen X, Engel PJ, Bowman ME, McGrath SA, Bisits AM, McElduff P, Giles WB, Smith DW. Patterns of plasma corticotropin-releasing hormone, progesterone, estradiol, and estriol change and the onset of human labor. J Clin Endocrinol Metab. 2009 Jun;94(6):2066-74. doi: 10.1210/jc.2008-2257. Epub 2009 Mar 3.
Background: PubMed 22759411Ceccaldi PF, Saada J, Nicolas M, Ducarme G, Blot P, Guibourdenche J, Luton D. Modulation of free corticotrophin-releasing hormone, adrenal and placental steroid hormone levels induced by mifepristone during pregnancy. Fetal Diagn Ther. 2012;32(4):267-70. doi: 10.1159/000338927. Epub 2012 Jul 4.
Background: PubMed 2407284Rodger MW, Baird DT. Pretreatment with mifepristone (RU 486) reduces interval between prostaglandin administration and expulsion in second trimester abortion. Br J Obstet Gynaecol. 1990 Jan;97(1):41-5. doi: 10.1111/j.1471-0528.1990.tb01714.x.
Background: PubMed 2918074Urquhart DR, Bahzad C, Templeton AA. Efficacy of the antiprogestin mifepristone (RU 486) prior to prostaglandin termination of pregnancy. Hum Reprod. 1989 Feb;4(2):202-3. doi: 10.1093/oxfordjournals.humrep.a136872.
Background: PubMed 9794673Elliott CL, Brennand JE, Calder AA. The effects of mifepristone on cervical ripening and labor induction in primigravidae. Obstet Gynecol. 1998 Nov;92(5):804-9. doi: 10.1016/s0029-7844(98)00284-1.
Background: PubMed 26243986Yelikar K, Deshpande S, Deshpande R, Lone D. Safety and Efficacy of Oral Mifepristone in Pre-induction Cervical Ripening and Induction of Labour in Prolonged Pregnancy. J Obstet Gynaecol India. 2015 Jul;65(4):221-5. doi: 10.1007/s13224-014-0584-6. Epub 2014 Jul 11.
Background: PubMed 28898687Baev OR, Rumyantseva VP, Tysyachnyu OV, Kozlova OA, Sukhikh GT. Outcomes of mifepristone usage for cervical ripening and induction of labour in full-term pregnancy. Randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2017 Oct;217:144-149. doi: 10.1016/j.ejogrb.2017.08.038. Epub 2017 Sep 1.
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.

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 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 31 May 2024. 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 Portugal. 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?

Number of Participants with Bishop score ≥6 or spontaneous labour (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 NCT04271722, which also lists 10 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 31 May 2024.