Evaluation of Maternal and Neonatal Outcomes Among Lebanese Women Conceived Through Assisted Reproductive Technology (non)

NCT06836843 ACTIVE_NOT_RECRUITING

Background: The number of couples experiencing difficulties conceiving and seeking treatment for infertility has increased dramatically over time. Treatment options for infertility have evolved significantly over the past four decades, expanding to include assisted reproductive technologies (ART). However, the impact of ART on pregnancy outcomes remains unclear. Studies have shown that ART pregnancies are associated with a higher risk of maternal and neonatal adverse outcomes compared to those resulting from spontaneous conception. To this date, no comprehensive studies have been conducted in Lebanon to assess this association. Therefore, it is crucial to evaluate whether Lebanese women who conceive via ART are at higher risk for maternal and birth-related complications. Objective: The aim of this study is to evaluate maternal and neonatal outcomes among women who conceived through assisted reproductive technology (ART), compared to those who conceived via other fertility treatments or naturally, at Dr. Ghazeeri's clinic at the American University of Beirut Medical Center. Methods: Investigators propose to conduct an observational retrospective cohort study involving all pregnant women treated by Dr. Ghazeeri who delivered at the American University of Beirut Medical Center between 2018 and 2023. Pregnancies exposed to assisted reproductive technology (ART) or other fertility treatments will be matched to a group of spontaneous pregnancies based on propensity scores. The study has been initiated following approval from the Institutional Review Board (IRB) at the American University of Beirut Medical Center. Data analysis will be performed using SPSS version 26. Expected Results: If no associations are found between ART or other fertility treatments and an increased risk of maternal and neonatal outcomes, the results will provide reassurance for mothers seeking these treatments. However, if associations are identified, policymakers will need to establish comprehensive regulations outlining the appropriate use of these technologies. Additionally, these findings would lay the groundwork for obstetricians to implement closer monitoring and more careful management during pregnancy.

Details

Lead sponsor	Lebanese University
Status	ACTIVE_NOT_RECRUITING
Enrolment	1000
Start date	2023-09-01
Completion	2025-08

Conditions

• Preterm Birth
• Gestational Diabetes Mellitus (GDM)
• Gestational Hypertension

Interventions

• Since this is an observational study rather than an interventional study, the exposure type refers to all potential factors influencing pregnancy both before and during pregnancy

Primary outcomes

• Percentage of Pregnant Women with Gestational Diabetes Mellitus (GDM) in the Exposed Group versus Non-Exposed Group — 24-28 weeks of gestation
  GDM will be diagnosed using standardized glucose screening tests; Oral Glucose Tolerance Test (OGTT) between 24 and 28 weeks of gestation. One-hour OGTT (after drinking a 50g glucose solution): Different cut-off thresholds are used for the 50-g glucose tolerance screening to be considered an abnormal result, including ≥130 mg/dL , ≥135 mg/dL, and ≥140 mg/dL. * Possible Gestational Diabetes (possible diagnosis if ≥140 mg/dL); and here the patient requires a confirmatory diagnosis which is the three-hours OGTT (after drinking 100g glucose solution): * Normal \<140 mg/dL * Gestational Diabetes ≥140 mg/dL
• Percentage of Pregnant Women with Gestational Hypertension in the Exposed Group versus the Non-Exposed Group — from 20 weeks + 1 day to 40 weeks of gestation
  Gestational hypertension is confirmed when blood pressure greater than or equal to 140mmHg systolic or 90mmHg diastolic on 2 separate occasions at least 4 hours apart after 20 weeks of pregnancy when previous blood pressure was normal
• Percentage of Babies Born Preterm to Women in the Exposed Group versus Non-Exposed Group — Before 37 weeks of gestation
  Preterm is defined as babies born alive before 37 weeks of pregnancy are completed.
• Percentage of Babies Born Small for Gestational Age to Women in the Exposed Group versus Non-Exposed Group — day one of birth
  Infants with a birth weight below the 10th percentile for their gestational age.
• Percentage of Babies Born Large for Gestational Age to Women in the Exposed Group versus Non-Exposed Group — day one of birth
  Infants with a birth weight above the 90th percentile for their gestational age

Countries

Lebanon