DOuble-BAlloon Versus PROstaglandin E2 for Cervical Ripening in Low Risk Pregnancies

NCT04747301 | Recruiting DMC

• 1 other identifier: PSHN.0001.2021
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the effectiveness and safety of double balloon catheter and vaginal insert Prostaglandin E2 in cervical ripening prior to Induction of Labor in low-risk women from 39+0 to 40+6 weeks of gestation.

Conditions

Induction of Labor

Keywords

Induction of labor; Low-risk pregnancies; Double-balloon catheter; Prostaglandin E2

Outcome Measures

Primary Outcomes (1)

• Number of participants delivered vaginally

  Number of participants delivered vaginally

  From randomization until delivery, assessed up to 3 days after randomization

Secondary Outcomes (37)

• Number of participants with Side - effect of induction's method

  From induction until delivery, assessed up to 3 days after induction

• Number of participants using more than one induction agent required

  From induction until delivery, assessed up to 3 days after induction

• Number of participants having oxytocin augmentation

  From induction until delivery, assessed up to 3 days after induction

• Number of participants with uterine tachysystole

  From induction until delivery, assessed up to 3 days after induction

• Time from induction of labor to delivery

  From induction until delivery, assessed up to 3 days after induction

Study Arms (2)

Double-balloon catheter group

OTHER

Sweeping the membranes by UTAH CVX-RIPE® (Utah Medical Products, Inc, 7043 South 300 West, Midvale, Utah 84047 USA).

Device: Double-balloon catheter (UTAH CVX-RIPE) for cervical ripening

Vaginal insertion Prostaglandin E2 group

OTHER

Propess® 10mg Vaginal delivery system (Ferring Controlled Therapeutics Ltd., 1 Redwood Place, Peel Park Campus, East Kilbride, Glasgow, G74 5PB, UK) is a vaginal insert containing 10mg of dinoprostone in a timed-release formulation (the medication is released at 0.3 mg/hour).

Drug: Dinoprostone 10mg (Propess)

Interventions

Double-balloon catheter (UTAH CVX-RIPE) for cervical ripening DEVICE

Sweeping the membranes by UTAH CVX-RIPE® (Utah Medical Products, Inc, 7043 South 300 West, Midvale, Utah 84047 USA). The catheter will be inserted manually until the proximal balloon is in the cervical canal, the distal balloon should be intrauterine and in the extra-amniotic space. The intrauterine balloon is inflated with 40mL saline and retracted so that it rests against the internal oz. The proximal balloon should now be outside the external oz and is inflated with 20mL saline. If the balloons are correctly situated on both ends of the cervix, they can be inflated with up to 80mL saline each. Cardiotocograph will be performed 30min, 2 hours after insertion and every 6 hours. The balloon is placed for a maximum of 24 hours. If it is expelled in the first 12 hours and the patient has no contractions or still shows an unfavorable cervix, another balloon is placed for a maximum of another 24 hours. The patients will be examined in case of extremely painful or membranes ruptured.

Double-balloon catheter group

Dinoprostone 10mg (Propess) DRUG

Propess® 10mg Vaginal delivery system (Ferring Controlled Therapeutics Ltd., 1 Redwood Place, Peel Park Campus, East Kilbride, Glasgow, G74 5PB, UK) is a vaginal insert containing 10mg of dinoprostone in a timed-release formulation (the medication is released at 0.3 mg/hour). A Propess vaginal system is inserted by a research doctors. As in the catheter procedure, Fetal Heart Rate is monitored 30min before and 2 hours after placement. Cardiotocograph and vaginal examination will be performed every 6 hours. The vaginal system is placed for a maximum of 24 hours. If it is expelled in the first 12 hours and the patient has no contractions or still shows an unfavorable cervix, another vaginal system is placed for a maximum of another 24 hours. The patients will be examined in case of extreme pain or membranes ruptured.

Also known as: Vaginal Prostaglandin E2 (Propess)

Vaginal insertion Prostaglandin E2 group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Maternal age ≥ 18
• Singleton pregnancy. Twin gestation reduced to singleton, either spontaneously or therapeutically, is not eligible unless the reduction occurred before 14 weeks gestational age.
• Gestational age at randomization from at 39+0 to 40+6 weeks of gestation.
• Cephalic presentation
• Intact membrane
• Unfavourable cervix (Bishop\<6)
• Informed consent

You may not qualify if:

• Maternal medical illness associated with increased risk of adverse pregnancy outcome (any diabetes mellitus, any hypertensive disorders, cardiac diseases, renal insufficiency, systemic lupus erythematosus, mental disorders, HIV positive, use of heparin or low-molecular weight heparin during the current pregnancy etc.)
• Abnormal placenta: Active vaginal bleeding greater than bloody show or placenta previa, accreta or vasa previa
• Abnormal amniotic fluid volume:
• Oligohydramnios (MVP \< 2cm)
• Polyhydramnios (MVP \> 10cm)
• Abnormal fetus
• Fetal demise or known major fetal anomalies
• Fetal growth restriction (FGR) (EFW \< 3% or \< 10% and abnormal Doppler)
• Non-reassuring fetal status (no fetal movements, abnormal fetal heart rate at auscultation)
• Previous C-section
• Planned for C-section or contra-indication to labour
• Cerclage or use of pessary in current pregnancy
• Refusal of blood product.
• Participation in another interventional study that influences management of labour at delivery or perinatal morbidity or mortality

Sponsors & Collaborators

• Hanoi Obstetrics and Gynecology Hospital: lead
• Mỹ Đức Hospital: collaborator

Study Sites (1)

Hanoi Obstetrics and Gynecology Hospital

Hanoi, Hanoi, 10000, Vietnam

RECRUITING

Related Publications (10)

• Du YM, Zhu LY, Cui LN, Jin BH, Ou JL. Double-balloon catheter versus prostaglandin E2 for cervical ripening and labour induction: a systematic review and meta-analysis of randomised controlled trials. BJOG. 2017 May;124(6):891-899. doi: 10.1111/1471-0528.14256. Epub 2016 Aug 17.

  PMID: 27533177 BACKGROUND

• Liu YR, Pu CX, Wang XY, Wang XY. Double-balloon catheter versus dinoprostone insert for labour induction: a meta-analysis. Arch Gynecol Obstet. 2019 Jan;299(1):7-12. doi: 10.1007/s00404-018-4929-8. Epub 2018 Oct 12.

  PMID: 30315411 BACKGROUND

• de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2019 Oct 18;10(10):CD001233. doi: 10.1002/14651858.CD001233.pub3.

  PMID: 31623014 BACKGROUND

• Shechter-Maor G, Haran G, Sadeh-Mestechkin D, Ganor-Paz Y, Fejgin MD, Biron-Shental T. Intra-vaginal prostaglandin E2 versus double-balloon catheter for labor induction in term oligohydramnios. J Perinatol. 2015 Feb;35(2):95-8. doi: 10.1038/jp.2014.173. Epub 2014 Oct 2.

  PMID: 25275693 BACKGROUND

• Du C, Liu Y, Liu Y, Ding H, Zhang R, Tan J. Double-balloon catheter vs. dinoprostone vaginal insert for induction of labor with an unfavorable cervix. Arch Gynecol Obstet. 2015 Jun;291(6):1221-7. doi: 10.1007/s00404-014-3547-3. Epub 2014 Nov 19.

  PMID: 25408273 BACKGROUND

• Wang W, Zheng J, Fu J, Zhang X, Ma Q, Yu S, Li M, Hou L. Which is the safer method of labor induction for oligohydramnios women? Transcervical double balloon catheter or dinoprostone vaginal insert. J Matern Fetal Neonatal Med. 2014 Nov;27(17):1805-8. doi: 10.3109/14767058.2014.880880. Epub 2014 Feb 3.

  PMID: 24397441 BACKGROUND

• Cromi A, Ghezzi F, Uccella S, Agosti M, Serati M, Marchitelli G, Bolis P. A randomized trial of preinduction cervical ripening: dinoprostone vaginal insert versus double-balloon catheter. Am J Obstet Gynecol. 2012 Aug;207(2):125.e1-7. doi: 10.1016/j.ajog.2012.05.020. Epub 2012 Jun 1.

  PMID: 22704766 BACKGROUND

• Suffecool K, Rosenn BM, Kam S, Mushi J, Foroutan J, Herrera K. Labor induction in nulliparous women with an unfavorable cervix: double balloon catheter versus dinoprostone. J Perinat Med. 2014 Mar;42(2):213-8. doi: 10.1515/jpm-2013-0152.

  PMID: 24096438 BACKGROUND

• Grobman WA, Rice MM, Reddy UM, Tita ATN, Silver RM, Mallett G, Hill K, Thom EA, El-Sayed YY, Perez-Delboy A, Rouse DJ, Saade GR, Boggess KA, Chauhan SP, Iams JD, Chien EK, Casey BM, Gibbs RS, Srinivas SK, Swamy GK, Simhan HN, Macones GA; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Labor Induction versus Expectant Management in Low-Risk Nulliparous Women. N Engl J Med. 2018 Aug 9;379(6):513-523. doi: 10.1056/NEJMoa1800566.

  PMID: 30089070 BACKGROUND

• Dos Santos F, Drymiotou S, Antequera Martin A, Mol BW, Gale C, Devane D, Van't Hooft J, Johnson MJ, Hogg M, Thangaratinam S. Development of a core outcome set for trials on induction of labour: an international multistakeholder Delphi study. BJOG. 2018 Dec;125(13):1673-1680. doi: 10.1111/1471-0528.15397. Epub 2018 Sep 10.

  PMID: 29981523 BACKGROUND

MeSH Terms

Interventions

Dinoprostone

Intervention Hierarchy (Ancestors)

Prostaglandins E; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Ben W Mol, PhD. MD

  Monash University

  STUDY CHAIR

• Anh Nguyen Duy, PhD. MD

  Hanoi Obstetric and Gynecology Hospital

  STUDY DIRECTOR

• Vinh Dang Quang, PhD. MD

  Mỹ Đức Hospital

  PRINCIPAL INVESTIGATOR

• Ha Nguyen Thi Thu, PhD. MD

  Hanoi Obstetrics and Gynecology Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ha Nguyen Thi Thu, PhD. MD

CONTACT

0084989661093; thuha.ivf@gmail.com

Toan Nguyen Khac, MSc. MD

CONTACT

0084948387988; ngkhactoan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Low-risk pregnant women eligible for study will be asked to sign the informed consent form. Then, they will be randomly assigned in a 1:1 ratio to receive either double balloon insertion or vaginal prostaglandin E2

Study Record Dates

• First Submitted: January 22, 2021
• First Posted: February 10, 2021
• Study Start: August 1, 2021
• Primary Completion: August 1, 2025
• Study Completion: December 31, 2025
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)