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

Primary Purpose

Fetal Growth Retardation, Induction of Labor Affected Fetus / Newborn

Status
Unknown status
Phase
Early Phase 1
Locations
Israel
Study Type
Interventional
Intervention
prostaglandins E2
intracervical balloon catheter combined with pitocin
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fetal Growth Retardation

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Lis Maternity Hospital, Tel Aviv Sourasky Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

prostaglandins

intracervical balloon catheter with pitocin

Arm Description

vaginal prostaglandins insertion (PGE2) for cervical ripening and induction

insertion of intra cervical balloon catheter combined with intravenous pitocin for ripening and induction of labor

Outcomes

Primary Outcome Measures

mode of delivery
vaginal delivery, instrumental delivery or cesarean delivery

Secondary Outcome Measures

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

Full Information

First Posted
July 31, 2018
Last Updated
August 9, 2018
Sponsor
Tel-Aviv Sourasky Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03625518
Brief Title
Mode of Induction in Fetal Growth Restriction and Its Affects on Fetal and Maternal Outcomes
Official Title
Mode of Induction in Fetal Growth Restriction and Its Affects on Fetal and Maternal Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2018 (Anticipated)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
January 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Growth Retardation, Induction of Labor Affected Fetus / Newborn

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
prostaglandins
Arm Type
Active Comparator
Arm Description
vaginal prostaglandins insertion (PGE2) for cervical ripening and induction
Arm Title
intracervical balloon catheter with pitocin
Arm Type
Active Comparator
Arm Description
insertion of intra cervical balloon catheter combined with intravenous pitocin for ripening and induction of labor
Intervention Type
Drug
Intervention Name(s)
prostaglandins E2
Other Intervention Name(s)
dinoprostone slow release pessary
Intervention Description
insertion of vaginal PGE2 for up to 30 hours, up to two attempts for cervical ripening and induction
Intervention Type
Device
Intervention Name(s)
intracervical balloon catheter combined with pitocin
Intervention Description
insertion of Foley catheter intra cervical and inflating the balloon with 50-60 cc of saline, with IV pitocin according to hospital protocol
Primary Outcome Measure Information:
Title
mode of delivery
Description
vaginal delivery, instrumental delivery or cesarean delivery
Time Frame
immediate
Secondary Outcome Measure Information:
Title
composite neonatal outcome
Description
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
Time Frame
3 months after delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ayelet Dangot, MD
Phone
972524262658
Email
adangot@gmail.com
Facility Information:
Facility Name
Lis Maternity Hospital, Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Kuperminc, MD
Phone
97236925633
First Name & Middle Initial & Last Name & Degree
Ayelet Dangot, MD
Phone
97236925633
First Name & Middle Initial & Last Name & Degree
Michael Kuperminc, MD
First Name & Middle Initial & Last Name & Degree
Ayelet Dangot, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24457811
Citation
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.
Results Reference
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PubMed Identifier
20205623
Citation
Baschat AA. Fetal growth restriction - from observation to intervention. J Perinat Med. 2010 May;38(3):239-46. doi: 10.1515/jpm.2010.041.
Results Reference
background
PubMed Identifier
18381841
Citation
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.
Results Reference
background
PubMed Identifier
21177352
Citation
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.
Results Reference
background
PubMed Identifier
23635765
Citation
ACOG Practice bulletin no. 134: fetal growth restriction. Obstet Gynecol. 2013 May;121(5):1122-1133. doi: 10.1097/01.AOG.0000429658.85846.f9.
Results Reference
background
PubMed Identifier
25354283
Citation
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.
Results Reference
background
PubMed Identifier
18506461
Citation
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.
Results Reference
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Mode of Induction in Fetal Growth Restriction and Its Affects on Fetal and Maternal Outcomes

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