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PREGNANCYNCT02754635

Induction Versus Expectant Management With Abnormal Maternal Biochemical Markers

A study testing Induction of labour and Expectant management in people with PREGNANCY, run by HaEmek Medical Center, Israel 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 The sponsor has not verified this record for over two years, so it may be out of date.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

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

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
PREGNANCY
What is being tested?
Induction of labour and Expectant management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
320 participants
Where
1 siteIsrael
Study dates
Mar 2016to Jul 2018
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 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Israel1 site, 1 recruiting

  • Emek medical center

    Afula, 18101

    Raed Salim, MD, 97246494031, salim_ra@clalit.org.il

    Manal Massalha, MD

    Recruiting

Other trials in Israel

About this study

Official title: Induction of Labor at Term Versus Expectant Management Among Women With Abnormal Maternal Serum Biochemical Markers: A Randomized Controlled Trial

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

Read the detailed description

Pregnancy-associated plasma protein A (PAPP-A), alpha-fetoprotein (AFP), human chorionic gonadotropin (hCG), and inhibin A, are biochemical markers that are part of the first and second trimester screening test, for Down syndrome and neural tube defects in pregnancy. These biochemical markers have been shown also to be associated with slightly increased risk for adverse pregnancy outcomes in the absence of aneuploidy or neural tube defects, for example; preeclampsia, low birth weight, placental abruption, preterm labor, and intrauterine fetal death.

There are no guidelines regarding the management of these cases assuming a reassuring maternal and fetal status are normal, at term (38 - 39 weeks). However, adverse events may still develop between 38 to 42 weeks when calculated according to ongoing pregnancy.

Investigators aim in this randomized trial to examine the effect of induction of labor at 38 - 39 weeks compared to expectant management among women with abnormal first or second biochemical screening tests on maternal and perinatal outcomes.

Enrollment: 320 women in both groups. Interim analyses will be performed after enrolling 50% of the participants.

Conditions
PREGNANCY
Being tested
Induction of labour, Expectant management
Keywords
Abnormal first or second trimester biochemical markers, maternal and perinatal morbidity/mortality

What participants receive

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

  • Induction of labourOther

    Induction of labour

  • Expectant managementOther

    Expectant management

Study groups in NCT02754635
Study groupRoleWhat they receive
Induction of labourActive comparatorInduction of labour at 38-39 weeks
Receives: Other: Induction of labour
Expectant managementActive comparatorExpectant management until 41 weeks.
Receives: Other: Expectant management

What is being measured

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

  1. Placental abruption

    Clinical diagnosis. Co-primary endpoint #1.

    Measured: 4 weeks

  2. Gestational hypertension

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

    Measured: 4 weeks

  3. Small of gestational age

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

    Measured: 4 weeks

  4. Intra-uterine death

    Fetal death. Co-primary endpoint #4

    Measured: 4 weeks

Secondary outcomes (3)

  1. Mode of delivery

    vaginal or cesarean.

    Measured: 4 weeks

  2. Intrapartum fever

    fever above 38C

    Measured: 4 weeks

  3. Neonatal Apgar score

    Apgar score

    Measured: 4 weeks

Timeline

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

  1. First posted28 Apr 2016 (estimated)
  2. Study startMar 2016
  3. Primary completionMay 2018 (estimated)
  4. Study completionJul 2018 (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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
320 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02754635
Sponsor's protocol ID
00126-15-EMC
Status last verified
Aug 2017
First submitted
23 Feb 2016
Last updated
16 Aug 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 19457604

  • 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.

    PubMed 17621365

  • 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.

    PubMed 16522419

  • 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.

    PubMed 19038077

  • 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.

    PubMed 9548180

  • 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.

    PubMed 10914623

  • 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.

    PubMed 20132984

  • 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.

    PubMed 22905470

  • 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.

    PubMed 16055573

  • 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.

    PubMed 14586353

  • 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.

    PubMed 17825674

  • 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.

    PubMed 7485303

Questions about this trial

What is this clinical trial studying?

A study testing Induction of labour and Expectant management in people with PREGNANCY, run by HaEmek Medical Center, Israel 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 5 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 16 Aug 2017. 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.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Placental abruption (time frame: 4 weeks). The study lists 4 primary outcomes in all. 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 NCT02754635, which also lists 12 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 16 Aug 2017.

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