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Induction of LaborDOBA-PRONCT04747301

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

A study testing Double-balloon catheter (UTAH CVX-RIPE) for cervical ripening and Dinoprostone 10mg (Propess) in people with Induction of Labor, run by Hanoi Obstetrics and Gynecology Hospital at 1 site in Vietnam.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Induction of Labor
What is being tested?
Double-balloon catheter (UTAH CVX-RIPE) for cervical ripening and Dinoprostone 10mg (Propess)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
540 participants
Where
1 siteVietnam
Study dates
1 Aug 2021to 31 Dec 2025
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Ha Nguyen Thi Thu, PhD. MD contact

0084989661093

thuha.ivf@gmail.com

Toan Nguyen Khac, MSc. MD contact

0084948387988

ngkhactoan@gmail.com

Vietnam1 site, 1 recruiting

  • Hanoi Obstetrics and Gynecology Hospital

    Hanoi, Hanoi, 10000

    Ha Thu Thi Nguyen, MD.PhD, 0084989661093, thuha.ivf@gmail.com

    Toan Nguyen Khac, MD.MSc, 0084948387988, ngkhactoan@gmail.com

    Recruiting

Other trials in Vietnam

About this study

Official title: The Effectiveness and Safety of Double-balloon Versus Vaginal Prostaglandin for Cervical Ripening in Women With Low-risk Pregnancies: A Randomized Controlled Trial (DOBA-PRO)

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.

Read the detailed description

Induction of labor (IOL) is a technique to establish vaginal delivery when the risks for continuing the pregnancy for mother or baby are higher than the risks of delivery. In case the cervix is unripe, cervical ripening before the onset of labor is needed. The two main mechanisms of cervical ripening can be categorized as mechanical or pharmacological.

A Cochrane systematic review and other recent meta-analysis have shown that cervical ripening with a balloon is probably as effective as induction of labor with vaginal Prostaglandin E2. However, this conclusion is based on low to moderate quality evidence. Only a limited number of randomized clinical trials (RCTs) have been conducted. Many of those suffering from small sample sizes and different study subjects, i.e. high-risk subjects only, and mixed population.

In current practice, induction of labor is not only used in high-risk patients with clear indications for pregnancy termination. The ARRIVE trial has shown a significant benefit of labor induction over expectant management among the low-risk population. Based on this evidence, the American College of Obstetricians and Gynecologists (ACOG) has suggested: "It's time to induce of labor at 39th week of gestation". Since then, there is a trend in favoring elective induction before the due date over expectant management. Besides, more and more pregnant women want to shorten the duration of pregnancy or to time the birth of the baby due to the convenience of the mother and/or healthcare workers.

This makes the optimal method of Induction of Labor in terms of effectiveness and safety for both mothers and their babies even more important. In this study, the investigators will compare the effectiveness and safety of double-balloon catheter and Prostaglandin E2 for elective labor induction in low-risk pregnancies.

Being tested
Double-balloon catheter (UTAH CVX-RIPE) for cervical ripening, Dinoprostone 10mg (Propess)
Keywords
Induction of labor, Low-risk pregnancies, Double-balloon catheter, Prostaglandin E2

What participants receive

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

  • Double-balloon catheter (UTAH CVX-RIPE) for cervical ripeningDevice

    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.

  • Dinoprostone 10mg (Propess)Drug

    Also called Vaginal Prostaglandin E2 (Propess)

    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.

Study groups in NCT04747301
Study groupRoleWhat they receive
Double-balloon catheter groupOtherSweeping the membranes by UTAH CVX-RIPE® (Utah Medical Products, Inc, 7043 South 300 West, Midvale, Utah 84047 USA).
Receives: Device: Double-balloon catheter (UTAH CVX-RIPE) for cervical ripening
Vaginal insertion Prostaglandin E2 groupOtherPropess® 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).
Receives: Drug: Dinoprostone 10mg (Propess)

What is being measured

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

  1. Number of participants delivered vaginally

    Number of participants delivered vaginally

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

Secondary outcomes (37)

  1. Number of participants with Side - effect of induction's method

    Including any of: nausea, vomiting, diarrhea, pain...

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

  2. Number of participants using more than one induction agent required

    Number of participants using more than one induction agent required

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

  3. Number of participants having oxytocin augmentation

    Number of participants having oxytocin augmentation

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

  4. Number of participants with uterine tachysystole

    Defined as more than 5 contractions in 10 minutes over a minimal period of two times 10 minutes with Fetal Heart Rate changes and/or a contraction lasting more than 3 minutes with Fetal Heart Rate changes.

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

  5. Time from induction of labor to delivery

    Duration from induction to delivery (hours)

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

  6. Number of participants delivered vaginally within 24 hours

    Number of participants delivered vaginally within 24 hours

    Measured: Within 24 hours from labor induction

  7. Number of participants with post-partum haemorrhage

    Defined as blood loss >500 ml at vaginal birth or >1000 ml at caesarean birth within 24 hours after birth

    Measured: Within 24 hours from delivery

  8. Number of participants having uterine atony

    Use of two or more uterotonics other than oxytocin; other surgical interventions such as uterine compression by hands and/or sutures, uterine artery ligation, embolization, hypogastric ligation, or balloon tamponade).

    Measured: From delivery until maternal hospital discharge, assessed up to 28 days after delivery

  9. Number of participants having maternal post-partum blood transfusion

    Number of participants having maternal post-partum blood transfusion

    Measured: From delivery until maternal hospital discharge, assessed up to 28 days after delivery

  10. Number of participants with hypertension complications

    Number of participants with hypertension complications

    Measured: From randomization until maternal hospital discharge, assessed up to 28 days after randomization

  11. Number of participants with uterine dehiscence or rupture

    Uterine dehiscence (defined as clinically asymptomatic disruption of the uterus that is discovered incidentally at surgery) or rupture (defined as clinically significant rupture involving the full thickness of the uterine wall and requiring surgical repair)

    Measured: From delivery until maternal hospital discharge, assessed up to 28 days after delivery

  12. Number of participants with maternal infection

    • Fever (defined as a temperature ≥37.5 degrees Celsius)
    • Start of intravenous broad-spectrum antibiotics (with evidence of infection confirmed by clinical and subclinical presentation)
    • Endometritis, myometritis or urinary tract infection (proven positive vaginal discharge/urine culture)

    Measured: From induction until maternal hospital discharge, assessed up to 28 days after induction

  13. Number of participants with hysterectomy

    Hysterectomy for any postpartum complications

    Measured: From delivery until maternal hospital discharge, assessed up to 28 days after delivery

  14. Number of participants with damage to internal organs

    Including intestines, bladder or ureters

    Measured: From delivery until maternal hospital discharge, assessed up to 28 days after delivery

  15. Number of participants with other post-partum complications

    Includes: venous embolism, pulmonary embolism, stroke, cardiac arrest

    Measured: From randomization until maternal hospital discharge, assessed up to 28 days after randomization

  16. Number of participants admitted to intensive care unit

    Number of participants admitted to intensive care unit

    Measured: From randomization until maternal hospital discharge, assessed up to 28 days after randomization

  17. Number of maternal death among participants

    Maternal death from randomization through hospital discharge

    Measured: From randomization until maternal hospital discharge, assessed up to 28 days after randomization

  18. Number of participants referred to other hospital due to severe morbidities

    Including: pulmonary embolus, stroke, cardiorespiratory arrest, etc.

    Measured: From randomization until maternal hospital referral, assessed up to 28 days after randomization

  19. Maternal length of stay

    Duration of stay in hospital (days)

    Measured: From admission until maternal hospital discharge, assessed up to 28 days after admission

  20. Psychometric aspects

    Feelings and thoughts pregnant women at antepartum and postpartum will be evaluated by Wijma Delivery Expectancy/Experience Questionnaires' (W-DEQ) version A and version B, respectively, expected to be filled out in approximately 30 minutes

    This is a questionnaire which measures a construct of fear related to childbirth during pregnancy and after delivery by asking the woman about her expectancies before delivery(version A) - performed at admission, and experiences after delivery (version B) - performed before maternal hospital discharge respectively.

    When filling in the W-DEQ, the woman is instructed to rate her personal feelings and cognitions on a six-point scale. The minimum score is 0 and the maximum score is 126. The higher the score, the greater the fear of childbirth manifested.

    Measured: At admission (version A) and before maternal hospital discharge (version B), assessed up to 28 days after admission

  21. Apgar scores at 1 and 5 minute

    Apgar scores at 1 and 5 minute

    Measured: Assessed at 1 and 5 minute after birth

  22. Number of Infants with Apgar Score ≤7 at 1 and 5 minutes

    Infants with Apgar Score ≤7 at 1 and 5 minutes

    Measured: Assessed at 1 and 5 minute after birth

  23. Number of neonates admitted to the Neonatal Intensive Care Unit or Intermediate care unit

    Number of neonates admitted to the Neonatal Intensive Care Unit or Intermediate care unit

    Measured: From delivery until admission to Neonatal Intensive Care Unit or Intermediate care unit, assessed up to 7 days after delivery

  24. Reason for Neonatal Intensive Care Unit admission

    Reason for Neonatal Intensive Care Unit admission such as: respiratory distress, hypoglycemia, seizures, etc.

    Measured: From delivery until Neonatal Intensive Care Unit admission, assessed up to 28 days after delivery

  25. Length of stay at the Neonatal Intensive Care Unit or Intermediate care unit

    Duration from admission to Neonatal Intensive Care Unit or Intermediate care unit to Neonatal Intensive Care Unit/ Intermediate care unit discharge or hospital referral

    Measured: From admission to Neonatal Intensive Care Unit/ Intermediate care unit until neonatal discharge or hospital referral, assessed up to 28 days after Neonatal Intensive Care Unit admission

  26. Number of neonates with birth trauma

    Include: bone fractures, traumatic pneumothorax, facial nerve palsy, other neurologic injury (Brachial plexus palsy...), etc.

    Measured: From delivery until neonatal hospital discharge, assessed up to 28 days after delivery

  27. Number of neonates with hypoglycemia

    Number of neonates with hypoglycemia

    Measured: From delivery until neonatal hospital discharge, assessed up to 28 days after delivery

  28. Number of neonates with jaundice and hyperbilirubinemia

    Number of neonates with jaundice and hyperbilirubinemia

    Measured: From delivery until neonatal hospital discharge, assessed up to 28 days after delivery

  29. Number of neonates with Hypoxic ischemic encephalopathy or need for therapeutic hypothermia

    Number of neonates with Hypoxic ischemic encephalopathy or need for therapeutic hypothermia

    Measured: From delivery until neonatal hospital discharge, assessed up to 28 days after delivery

  30. Number of neonates with meconium aspiration syndrome

    Criteria include:

    • Meconium-stained amniotic fluid
    • Respiratory distress at birth or shortly after birth
    • Characteristic radiographic features: The initial chest film may show streaky, linear densities -> the lungs typically appear hyper-inflated with flattening of the diaphragms.

    Measured: From delivery until neonatal hospital discharge, assessed up to 07 days after delivery

  31. Number of neonates in need for respiratory supports

    Incubation, Continuous Positive Airway Pressure, or high-flow nasal cannula (HFNC) for ventilation or cardiopulmonary resuscitation within the first 72 hours

    Measured: From delivery until neonatal hospital discharge, assessed up to 28 days after delivery

  32. Number of neonates with neonatal infection

    Presence of a clinically ill infant in whom systemic infection is suspected with a positive blood, cerebrospinal fluid (CSF), or catheterized/supra-pubic urine culture; or, in the absence of positive cultures, clinical evidence of cardiovascular collapse or an X-ray confirming infection

    Measured: From delivery until neonatal hospital discharge, assessed up to 28 days after delivery

  33. Number of neonates with neonatal seizures

    Number of neonates with neonatal seizures

    Measured: From delivery until neonatal hospital discharge, assessed up to 28 days after delivery

  34. Number of neonates with intracranial hemorrhage

    Intra-ventricular hemorrhage grades III and IV, subgaleal hematoma, subdural hematoma, or subarachnoid hematoma Subgaleal hematoma, subdural hematoma, or subarachnoid hematoma

    Measured: From delivery until neonatal hospital discharge, assessed up to 28 days after delivery

  35. Number of neonates need blood transfusion

    Number of neonates need blood transfusion

    Measured: From delivery until neonatal hospital discharge, assessed up to 28 days after delivery

  36. Number of neonatal deaths

    Includes: Intrapartum/neonatal/perinatal deaths

    Measured: From delivery until neonatal hospital discharge, assessed up to 28 days after delivery

  37. Number of neonates referred to other hospital for severe morbidities

    Number of neonates referred to other hospital for severe morbidities

    Measured: From delivery until neonatal hospital referral, assessed up to 28 days after delivery

Timeline

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

  1. First posted10 Feb 2021
  2. Study start1 Aug 2021
  3. Primary completion1 Aug 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

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
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
Masking
None (open label)
Enrolment
540 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04747301
Sponsor's protocol ID
PSHN.0001.2021
Acronym
DOBA-PRO
Status last verified
Feb 2024
First submitted
22 Jan 2021
Last updated
1 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27533177

  • 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.

    PubMed 30315411

  • 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.

    PubMed 31623014

  • 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.

    PubMed 25275693

  • 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.

    PubMed 25408273

  • 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.

    PubMed 24397441

  • 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.

    PubMed 22704766

  • 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.

    PubMed 24096438

  • 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.

    PubMed 30089070

  • 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.

    PubMed 29981523

Questions about this trial

What is this clinical trial studying?

A study testing Double-balloon catheter (UTAH CVX-RIPE) for cervical ripening and Dinoprostone 10mg (Propess) in people with Induction of Labor, run by Hanoi Obstetrics and Gynecology Hospital at 1 site in Vietnam.

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 7 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 1 Mar 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 Vietnam. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ha Nguyen Thi Thu, PhD. MD (0084989661093, thuha.ivf@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants delivered vaginally (time frame: From randomization until delivery, assessed up to 3 days after randomization). 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 NCT04747301, 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 1 Mar 2024.

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