Induction Versus Expectant Management With Abnormal Maternal Biochemical Markers
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|ClinicalTrials.gov Identifier: NCT02754635|
Recruitment Status : Unknown
Verified August 2017 by Manal Massalha, HaEmek Medical Center, Israel.
Recruitment status was: Recruiting
First Posted : April 28, 2016
Last Update Posted : August 16, 2017
|Condition or disease||Intervention/treatment||Phase|
|PREGNANCY||Other: Induction of labour Other: Expectant management||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||320 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Induction of Labor at Term Versus Expectant Management Among Women With Abnormal Maternal Serum Biochemical Markers: A Randomized Controlled Trial|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||July 2018|
Active Comparator: Induction of labour
Induction of labour at 38-39 weeks
Other: Induction of labour
Induction of labour
Active Comparator: Expectant management
Expectant management until 41 weeks.
Other: Expectant management
- Placental abruption [ Time Frame: 4 weeks ]Clinical diagnosis. Co-primary endpoint #1.
- Gestational hypertension [ Time Frame: 4 weeks ]Blood pressure above 140/90 mmHg. Co-primary endpoint #2
- Small of gestational age [ Time Frame: 4 weeks ]Birth Weight less than the 10th percentile. Co-primary endpoint #3
- Intra-uterine death [ Time Frame: 4 weeks ]Fetal death. Co-primary endpoint #4
- Mode of delivery [ Time Frame: 4 weeks ]vaginal or cesarean.
- Intrapartum fever [ Time Frame: 4 weeks ]fever above 38C
- Neonatal Apgar score [ Time Frame: 4 weeks ]Apgar score
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02754635
|Emek medical center||Recruiting|
|Afula, Israel, 18101|
|Contact: Raed Salim, MD 97246494031 firstname.lastname@example.org|
|Principal Investigator: Manal Massalha, MD|
|Study Chair:||Raed Salim||Emek Medical Center|