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Fetal Growth RetardationEarly Phase 1NCT03625518

Mode of Induction in Fetal Growth Restriction and Its Affects on Fetal and Maternal Outcomes

A Early Phase 1 study testing prostaglandins E2 and intracervical balloon catheter combined with pitocin in people with Fetal Growth Retardation and Induction of Labor Affected Fetus / Newborn, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

to compare methods of induction of labor in fetal growth restriction and its effect on maternal and neonatal outcome Read more about this study

Who is it for?
Ages 18 to 50 years, women only
What is being tested?
prostaglandins E2 and intracervical balloon catheter combined with pitocin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
280 participants
Where
1 siteIsrael
Study dates
Sep 2018to Jan 2021
Phase
Early Phase 1
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 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • singleton pregnancy
  • fetal growth restriction defined as estimated fetal weight between the 3rd and 10th percentile per gestational age and are intended to deliver vaginally
  • Gestational age between 36 and 42 weeks
  • No known fetal anomalies

Who cannot join

  • Fetal estimated weight below the 3rd percentile
  • Known fetal anomalies
  • Contraindications for vaginal delivery: breech presentation, abnormal Doppler flow velocimetry of fetal ductus venosus.
  • Oligohydramnios defined as amniotic fluid index below 5 cm
  • Contraindication to the use of prostaglandins
  • Fetal distress requiring emergent cesarean section
  • All other condition preventing vaginal delivery as decided by a senior physician

Trial locations and contacts

1 site in 1 country.

Ayelet Dangot, MD contact

972524262658

adangot@gmail.com

Israel1 site

  • Lis Maternity Hospital, Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

    Michael Kuperminc, MD, 97236925633

    Ayelet Dangot, MD, 97236925633

Other trials in Israel

About this study

to compare methods of induction of labor in fetal growth restriction and its effect on maternal and neonatal outcome

Read the detailed description

Intra uterine growth restriction (FGR) is a condition in which the fetus does not realize its growth potential in uterus. The excepted definitions of this condition are fetal weight estimation below the 10th percentile per gestational week. Severe growth restriction is defined as estimated weight below the 3rd percentile. It is well known that fetuses which are growth restricted are subjected to a higher degree of complications during pregnancy and delivery such as fetal distress, hypoxic damage, intra uterine fetal demise and complications in the neonatal period including prolonged NICU hospitalization, cerebral palsy, hypoxic ischemic encephalopathy and also long term affects such as neuro developmental complications.

Common practice in managing these cases is induction of labor at term around 37 weeks of gestations to prevent these complications as it established that during this time there is a substantial rise in pregnancy complications including fetal demise.

There are no clear guide lines how to induce labor in such cases and it is not known what is the safest and the most effective way to induce labor in these cases. Prior studies have found the rate of successful vaginal birth in these cases vary between 50 and 80%. There are a number of methods of labor induction and delivery available including the use of vaginal prostaglandins (PGE2) for cervical ripening, intracervical balloon catheter or planned cesarean. In most cases when aiming for vaginal delivery the choice is between ripening of the cervix with balloon catheter in combination with Pitocin or ripening with prostaglandins. It is not known which method is safer and more successful in growth restricted fetuses.

Being tested
prostaglandins E2, intracervical balloon catheter combined with pitocin
Medical subject headings
Fetal Growth Retardation

What participants receive

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

  • prostaglandins E2Drug

    Also called dinoprostone slow release pessary

    insertion of vaginal PGE2 for up to 30 hours, up to two attempts for cervical ripening and induction

  • intracervical balloon catheter combined with pitocinDevice

    insertion of Foley catheter intra cervical and inflating the balloon with 50-60 cc of saline, with IV pitocin according to hospital protocol

Study groups in NCT03625518
Study groupRoleWhat they receive
prostaglandinsActive comparatorvaginal prostaglandins insertion (PGE2) for cervical ripening and induction
Receives: Drug: prostaglandins E2
intracervical balloon catheter with pitocinActive comparatorinsertion of intra cervical balloon catheter combined with intravenous pitocin for ripening and induction of labor
Receives: Device: intracervical balloon catheter combined with pitocin

What is being measured

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

  1. mode of delivery

    vaginal delivery, instrumental delivery or cesarean delivery

    Measured: immediate

Secondary outcomes (1)

  1. composite neonatal outcome

    apgar score at birth, umilical cord blood gases, neonatal intensive care unit hospitalization,Intra ventricular hemorrhage, periventricular leukomalacia, meconium aspiration syndrome, sepsis, convulsion, perinatal death, need for hypothermia treatment

    Measured: 3 months 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 Aug 2018
  2. Study startSep 2018 (estimated)
  3. Primary completionJul 2020 (estimated)
  4. Study completionJan 2021 (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
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
280 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03625518
Sponsor's protocol ID
0114-18
Status last verified
Aug 2018
First submitted
31 Jul 2018
Last updated
10 Aug 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Figueras F, Gratacos E. Update on the diagnosis and classification of fetal growth restriction and proposal of a stage-based management protocol. Fetal Diagn Ther. 2014;36(2):86-98. doi: 10.1159/000357592. Epub 2014 Jan 23.

    PubMed 24457811

  • Baschat AA. Fetal growth restriction - from observation to intervention. J Perinat Med. 2010 May;38(3):239-46. doi: 10.1515/jpm.2010.041.

    PubMed 20205623

  • Walker DM, Marlow N. Neurocognitive outcome following fetal growth restriction. Arch Dis Child Fetal Neonatal Ed. 2008 Jul;93(4):F322-5. doi: 10.1136/adc.2007.120485. Epub 2008 Apr 1.

    PubMed 18381841

  • Boers KE, Vijgen SM, Bijlenga D, van der Post JA, Bekedam DJ, Kwee A, van der Salm PC, van Pampus MG, Spaanderman ME, de Boer K, Duvekot JJ, Bremer HA, Hasaart TH, Delemarre FM, Bloemenkamp KW, van Meir CA, Willekes C, Wijnen EJ, Rijken M, le Cessie S, Roumen FJ, Thornton JG, van Lith JM, Mol BW, Scherjon SA; DIGITAT study group. Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT). BMJ. 2010 Dec 21;341:c7087. doi: 10.1136/bmj.c7087.

    PubMed 21177352

  • ACOG Practice bulletin no. 134: fetal growth restriction. Obstet Gynecol. 2013 May;121(5):1122-1133. doi: 10.1097/01.AOG.0000429658.85846.f9.

    PubMed 23635765

  • Horowitz KM, Feldman D. Fetal growth restriction: risk factors for unplanned primary cesarean delivery. J Matern Fetal Neonatal Med. 2015;28(18):2131-4. doi: 10.3109/14767058.2014.980807. Epub 2014 Nov 14.

    PubMed 25354283

  • Maslovitz S, Shenhav M, Levin I, Almog B, Ochshorn Y, Kupferminc M, Many A. Outcome of induced deliveries in growth-restricted fetuses: second thoughts about the vaginal option. Arch Gynecol Obstet. 2009 Feb;279(2):139-43. doi: 10.1007/s00404-008-0685-5. Epub 2008 May 28.

    PubMed 18506461

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing prostaglandins E2 and intracervical balloon catheter combined with pitocin in people with Fetal Growth Retardation and Induction of Labor Affected Fetus / Newborn, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.

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 4 inclusion and 7 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 10 Aug 2018. 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 Israel. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Ayelet Dangot, MD (972524262658, adangot@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

mode of delivery (time frame: immediate). 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 NCT03625518, which also lists 7 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 10 Aug 2018.

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