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Induction of labor at term versus expectant management among women with abnormal maternal biochemical markers. A randomized controlled trial
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Induction of labour | Active Comparator | Induction of labour at 38-39 weeks |
|
| Expectant management | Active Comparator | Expectant management until 41 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Induction of labour | Other | Induction of labour |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mode of delivery | vaginal or cesarean. | 4 weeks |
| Intrapartum fever | fever above 38C | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raed Salim | Emek Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emek medical center | Recruiting | Afula | 18101 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19457604 | Result | 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. | |
| 17621365 | Result |
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| ID | Term |
|---|---|
| D007751 | Labor, Induced |
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D036861 | Delivery, Obstetric |
| D013513 | Obstetric Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D017063 | Outcome Assessment, Health Care |
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| Expectant management |
| Other |
Expectant management |
|
| Neonatal Apgar score | Apgar score | 4 weeks |
| 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. |
| 16522419 | Result | 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. |
| 19038077 | Result | 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. |
| 9548180 | Result | 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. |
| 10914623 | Result | 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. |
| 20132984 | Result | 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. |
| 22905470 | Result | 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. |
| 16055573 | Result | 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. |
| 14586353 | Result | 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. |
| 17825674 | Result | 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. |
| 7485303 | Result | 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. |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |