study of women undergoing prenatal invasive procedure: miscarriage rate and pregnancy outcome

Not Applicable

Completed

• Conditions: Health Condition 1: O9A2- Injury, poisoning and certain other consequences of external causes complicating pregnancy, childbirth and the puerperium

• Registration Number: CTRI/2020/11/029112
• Lead Sponsor: nil

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-06-30
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 150

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

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 (<= 25 mm) on transvaginal ultrasound in the second trimester

or women with cervical cerclage in-situ

iv. History of uncontrolled diabetes, hypertension, history of vaginal discharge

suggestive of vaginitis.

Study & Design

• Study Type: Observational
• Study Design: Not specified