Health Condition 1: O9A2- Injury, poisoning and certain other consequences of external causes complicating pregnancy, childbirth and the puerperium
Conditions
Interventions
None listed
Sponsors
nil
Eligibility
Inclusion criteria
Inclusion criteria: Women with a singleton or multiple pregnancy undergoing an invasive prenatal diagnostic procedure for various indications like i. Positive screening test for aneuploidy (combined screen in the first trimester, quadruple screen in the second trimester and NIPT in the first or second trimester) ii. Soft markers or a structural fetal anomaly detected on ultrasound iii. History of chromosomal anomaly or genetic defect in previous born child iv. Couple who is a known carrier of a genetic disorder
Exclusion criteria
Exclusion criteria: i. History of bleeding In last two weeks preceding planed procedure. ii. History of fever in the last 7 days before procedure. iii. Short cervical length ( or women with cervical cerclage in-situ iv. History of uncontrolled diabetes, hypertension, history of vaginal discharge suggestive of vaginitis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the composite adverse events (miscarriage up to 24 weeks, preterm premature labour rupture of membranes, preterm labour, preterm birth) following an ultrasound guided invasive prenatal diagnostic procedureTimepoint: five months, 7 months,9 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives: To determine the following after an ultrasound guided invasive prenatal diagnostic procedure 1. Indications of ultrasound guided invasive prenatal diagnostic procedure 2. Genetic results of above procedures 3. Pregnancy complications other than those included in composite adverse events e.g chorioamnionitis, fetal growth restriction, pre-eclampsia, any other 4. Pregnancy outcomeTimepoint: august 20 to December 2021 | — |
Countries
India
Contacts
Public ContactVivek Thakur
PGIMER, Chandigarh India
Outcome results
None listed