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
Verified date | August 2017 |
Source | HaEmek Medical Center, Israel |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Induction of labor at term versus expectant management among women with abnormal maternal biochemical markers. A randomized controlled trial
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. |
Country | Name | City | State |
---|---|---|---|
Israel | Emek medical center | Afula |
Lead Sponsor | Collaborator |
---|---|
HaEmek Medical Center, Israel |
Israel,
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
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 |
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