Induction Versus Expectant Management With Abnormal Maternal Biochemical Markers

PREGNANCY Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02754635
• Other study ID #: 00126-15-EMC
• Status: Recruiting
• Phase: N/A
• First received: February 23, 2016
• Last updated: August 13, 2017
• Start date: March 2016
• Est. completion date: July 2018

Study information

• Verified date: August 2017
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: July 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• PREGNANCY

Intervention

Other:
• Induction of labour
Induction of labour
• Expectant management
Expectant management

Locations

Country	Name	City	State
Israel	Emek medical center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

References & Publications (12)

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 gonadotr — View Citation

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. — View Citation

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 — View Citation

Gagnon A, Wilson RD, Audibert F, Allen VM, Blight C, Brock JA, Désilets VA, Johnson JA, Langlois S, Summers A, Wyatt P; Society of Obstetricians and Gynaecologists of Canada Genetics Committee. Obstetrical complications associated with abnormal maternal s — View Citation

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. — View Citation

Hossain N, Paidas MJ. Adverse pregnancy outcome, the uteroplacental interface, and preventive strategies. Semin Perinatol. 2007 Aug;31(4):208-12. Review. — View Citation

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. — View Citation

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. — View Citation

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):2 — View Citation

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. — View Citation

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 — View Citation

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: — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Placental abruption	Clinical diagnosis. Co-primary endpoint #1.	4 weeks
Primary	Gestational hypertension	Blood pressure above 140/90 mmHg. Co-primary endpoint #2	4 weeks
Primary	Small of gestational age	Birth Weight less than the 10th percentile. Co-primary endpoint #3	4 weeks
Primary	Intra-uterine death	Fetal death. Co-primary endpoint #4	4 weeks
Secondary	Mode of delivery	vaginal or cesarean.	4 weeks
Secondary	Intrapartum fever	fever above 38C	4 weeks
Secondary	Neonatal Apgar score	Apgar score	4 weeks