NCT02754635

Brief Summary

Induction of labor at term versus expectant management among women with abnormal maternal biochemical markers. A randomized controlled trial

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
320

participants targeted

Target at P75+ for not_applicable pregnancy

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2016

Completed
7 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 28, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

August 16, 2017

Status Verified

August 1, 2017

Enrollment Period

2.2 years

First QC Date

February 23, 2016

Last Update Submit

August 13, 2017

Conditions

PREGNANCY

Keywords

Abnormal first or second trimester biochemical markersmaternal and perinatal morbidity/mortality

Outcome Measures

Primary Outcomes (4)

  • Placental abruption

    Clinical diagnosis. Co-primary endpoint #1.

    4 weeks

  • Gestational hypertension

    Blood pressure above 140/90 mmHg. Co-primary endpoint #2

    4 weeks

  • Small of gestational age

    Birth Weight less than the 10th percentile. Co-primary endpoint #3

    4 weeks

  • Intra-uterine death

    Fetal death. Co-primary endpoint #4

    4 weeks

Secondary Outcomes (3)

  • Mode of delivery

    4 weeks

  • Intrapartum fever

    4 weeks

  • Neonatal Apgar score

    4 weeks

Study Arms (2)

Induction of labour

ACTIVE COMPARATOR

Induction of labour at 38-39 weeks

Other: Induction of labour

Expectant management

ACTIVE COMPARATOR

Expectant management until 41 weeks.

Other: Expectant management

Interventions

Induction of labourOTHER

Induction of labour

Induction of labour
Expectant managementOTHER

Expectant management

Expectant management

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • HCG, AFP or Inhibin greater than 2 multiple of median (MOM) or PAPPA less than 0.15 MOM.
  • Singleton.
  • Appropriate for gestational age fetus.
  • Reassuring fetal status including normal amniotic fluid index.

You may not qualify if:

  • Any hypertensive disorder.
  • Indication for induction of labour at enrollment.
  • Any contraindication of induction of labour.
  • Prior cesarean delivery.
  • Any contraindication for a trial of vaginal delivery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emek medical center

Afula, 18101, Israel

RECRUITING

Related Publications (12)

  • Yuan W, Chen L, Bernal AL. Is elevated maternal serum alpha-fetoprotein in the second trimester of pregnancy associated with increased preterm birth risk? A systematic review and meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2009 Jul;145(1):57-64. doi: 10.1016/j.ejogrb.2009.04.017. Epub 2009 May 19.

    PMID: 19457604RESULT

  • Ganapathy R, Lamont RF, Bassett P. Unexplained elevated maternal serum beta-HCG concentration and adverse pregnancy outcome. Prenat Diagn. 2007 Nov;27(11):995-9. doi: 10.1002/pd.1813.

    PMID: 17621365RESULT

  • Alkazaleh F, Chaddha V, Viero S, Malik A, Anastasiades C, Sroka H, Chitayat D, Toi A, Windrim RC, Kingdom JC. Second-trimester prediction of severe placental complications in women with combined elevations in alpha-fetoprotein and human chorionic gonadotrophin. Am J Obstet Gynecol. 2006 Mar;194(3):821-7. doi: 10.1016/j.ajog.2005.09.010.

    PMID: 16522419RESULT

  • Gagnon A, Wilson RD; SOCIETY OF OBSTETRICIANS AND GYNAECOLOGISTS OF CANADA GENETICS COMMITTEE. Obstetrical complications associated with abnormal maternal serum markers analytes. J Obstet Gynaecol Can. 2008 Oct;30(10):918-932. doi: 10.1016/S1701-2163(16)32973-5. English, French.

    PMID: 19038077RESULT

  • Luckas MJ, Sandland R, Hawe J, Neilson JP, McFadyen IR, Meekins JW. Fetal growth retardation and second trimester maternal serum human chorionic gonadotrophin levels. Placenta. 1998 Mar-Apr;19(2-3):143-7. doi: 10.1016/s0143-4004(98)90002-9.

    PMID: 9548180RESULT

  • Wax JR, Lopes AM, Benn PA, Lerer T, Steinfeld JD, Ingardia CJ. Unexplained elevated midtrimester maternal serum levels of alpha fetoprotein, human chorionic gonadotropin, or low unconjugated estriol: recurrence risk and association with adverse perinatal outcome. J Matern Fetal Med. 2000 May-Jun;9(3):161-4. doi: 10.1002/1520-6661(200005/06)9:33.0.CO;2-T.

    PMID: 10914623RESULT

  • Salim R, Okopnik M, Garmi G, Nachum Z, Zafran N, Shalev E. Lack of association between unexplained elevated maternal serum alpha fetoprotein and/or human chorionic gonadotropin and the occurrence of placental thrombotic lesions. Placenta. 2010 Apr;31(4):277-81. doi: 10.1016/j.placenta.2010.01.010. Epub 2010 Feb 4.

    PMID: 20132984RESULT

  • Saruhan Z, Ozekinci M, Simsek M, Mendilcioglu I. Association of first trimester low PAPP-A levels with adverse pregnancy outcomes. Clin Exp Obstet Gynecol. 2012;39(2):225-8.

    PMID: 22905470RESULT

  • Dugoff L, Hobbins JC, Malone FD, Vidaver J, Sullivan L, Canick JA, Lambert-Messerlian GM, Porter TF, Luthy DA, Comstock CH, Saade G, Eddleman K, Merkatz IR, Craigo SD, Timor-Tritsch IE, Carr SR, Wolfe HM, D'Alton ME; FASTER Trial Research Consortium. Quad screen as a predictor of adverse pregnancy outcome. Obstet Gynecol. 2005 Aug;106(2):260-7. doi: 10.1097/01.AOG.0000172419.37410.eb.

    PMID: 16055573RESULT

  • Caughey AB, Stotland NE, Escobar GJ. What is the best measure of maternal complications of term pregnancy: ongoing pregnancies or pregnancies delivered? Am J Obstet Gynecol. 2003 Oct;189(4):1047-52. doi: 10.1067/s0002-9378(03)00897-4.

    PMID: 14586353RESULT

  • Hossain N, Paidas MJ. Adverse pregnancy outcome, the uteroplacental interface, and preventive strategies. Semin Perinatol. 2007 Aug;31(4):208-12. doi: 10.1053/j.semperi.2007.05.002.

    PMID: 17825674RESULT

  • Konchak PS, Bernstein IM, Capeless EL. Uterine artery Doppler velocimetry in the detection of adverse obstetric outcomes in women with unexplained elevated maternal serum alpha-fetoprotein levels. Am J Obstet Gynecol. 1995 Oct;173(4):1115-9. doi: 10.1016/0002-9378(95)91336-x.

    PMID: 7485303RESULT

MeSH Terms

Interventions

Labor, InducedWatchful Waiting

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, OperativeOutcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Raed Salim

    Emek Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 23, 2016

First Posted

April 28, 2016

Study Start

March 1, 2016

Primary Completion

May 1, 2018

Study Completion

July 1, 2018

Last Updated

August 16, 2017

Record last verified: 2017-08

Locations

IL(1)