Clinical Evaluation of Cervical Ripening in the Outpatient Setting

NCT ID: NCT04271722

Last Updated: 2024-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-15
• Study Completion Date: 2022-12-30

Brief Summary

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mifepristone

Mifepristone 200mg 24hours before the induction day

Group Type: EXPERIMENTAL

Cervical ripening

Intervention Type: OTHER

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

Balloon catheter

Balloon catheter with 40ml placed 24hours before the induction day

Group Type: ACTIVE_COMPARATOR

Cervical ripening

Intervention Type: OTHER

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

Interventions

Cervical ripening

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Centro Hospitalar Lisboa Norte

OTHER

Sponsor Role: lead

Responsible Party

Maria de Carvalho Afonso

Medical Doctor, Phd Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Centro Hospitalar Lisboa Norte

Lisbon, , Portugal

Countries

Portugal

References

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Reference Type: BACKGROUND

PMID: 29211328 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14698071 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 19258402 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 22759411 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 2407284 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 2918074 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9794673 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26243986 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28898687 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28901007 (View on PubMed)

Other Identifiers

2020OBST1

Identifier Type: -

Identifier Source: org_study_id