A real-world observational study in Rh-negative pregnant women

Recruiting

• Conditions: Rh negative Pregnant women

• Registration Number: CTRI/2022/01/039101
• Lead Sponsor: Bharat serums and Vaccines Ltd

Brief Summary

This is a prospective, observational, data collection study. The study will collate the information of pregnant Rh-negative women who are treated in clinics and hospitals throughout India. All the relevant medical records of treated pregnant Rh-negative women will be retrieved for the study and entered in eCRF. The enrolled subject will be followed prospectively for the 3 months. The objectives of the study are to evaluate the geographical prevalence of the Rh-negative blood group, sensitization rate in pregnant women, usage of prophylactic treatment, complications in fetuses delivered by sensitized mothers, level of awareness, and quality of care provided to Rh-negative mothers.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-01
• Last Update Posted: 2025-03-18

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Female
• Target Recruitment: 20000

Inclusion Criteria

1. Subject who has provided the written informed consent form to participate in the study 2) Subject is ≥ 18 years of age 3) Rh-negative pregnant women.

Exclusion Criteria

1. Subject not willing to participate in the study.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) Subject demographics (age), anthropometric data (height, weight), vital signs	3 months of follow up period after date of enrolment
2) Family status & Rh-positive or Rh-negative status of husband and/or previous child	3 months of follow up period after date of enrolment
3) Previous pregnancy details (LMP, delivery date & type, ICT done or not, Rh sensitization, complications, history of miscarriages)	3 months of follow up period after date of enrolment
6) AE related to the use of anti-D and its causal assessment in relation to BSV product(s)	3 months of follow up period after date of enrolment
4) Current pregnancy details (LMP, trimester, details of blood test for Rh-negative, ICT result (if done), sensitization, anti-D use, other pregnancy-related regular medications)	3 months of follow up period after date of enrolment
5) Complications in current pregnancy (hemolytic anemia, kernicterus, icterus gravis neonatorum, hydrops fetalis), delivery type	3 months of follow up period after date of enrolment

Secondary Outcome Measures

Name	Time	Method
NA	NA

Trial Locations

Locations (811)

Devnandini Hospital; 🇮🇳 Meerut, UTTAR PRADESH, India

Jeevan Jyoti Hospital & Medical Research Centre; 🇮🇳 Gorakhpur, UTTAR PRADESH, India

Kailash Hospital Greater Noida; 🇮🇳 Nagar, UTTAR PRADESH, India

Aachahari nursing clinic; 🇮🇳 Patna, BIHAR, India

Aai Hospital & Maternity Home; 🇮🇳 Ahmadnagar, MAHARASHTRA, India

Aai Maternity Hospital; 🇮🇳 Jalgaon, MAHARASHTRA, India

Aakansha womens’s clinic; 🇮🇳 Kolkata, WEST BENGAL, India

Aanand Maternity Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

Aarati Maternity and Surgical Hospital,; 🇮🇳 Kantha, GUJARAT, India

Aastha Clinic; 🇮🇳 Ujjain, MADHYA PRADESH, India

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Devnandini Hospital

🇮🇳Meerut, UTTAR PRADESH, India

Dr Vimlesh Sharma

Principal investigator

9758735653

mail4vimlesh@gmail.com