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Improving maternal and foetal outcomes among pregnant women suffering from sickle cell disease in Gujarat, India

Effectiveness of Hydroxyurea along with standard of care compared to only standard of care on adverse maternal and foetal outcomes: A randomised controlled trial among pregnant women suffering from sickle cell disease in Gujarat, India - NIL

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/08/072780
Enrollment
98
Registered
2024-08-20
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D759- Disease of blood and blood-formingorgans, unspecified

Interventions

Intervention1: Hydroxyurea medicine and standard treatment: The intervention group will receive the current standard treatment and hydroxyurea medicine. Hydroxyurea will be started as per the national

Sponsors

SEWA Rural
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All consenting pregnant women with sickle cell disease seeking outpatient or inpatient care at Kasturba Maternity Hospital or its satellite center during the second trimester of pregnancy will be eligible for enrolment. Sickle cell disease status will be confirmed by a gold standard laboratory test- HPLC.

Exclusion criteria

Exclusion criteria: Dont, provide consent, out of study area, already on hydroxyurea treatment, not intended to get services at SEWA Rural, and those who have already the presence of contra indication to hydroxyurea medicine at baseline which includes neutropenia, thrombocytopenia, abnormal increase in serum creatinine, or hepatitis.

Design outcomes

Primary

MeasureTime frame
1.Adverse maternal outcome event score per person month will be primary outcome. 2.Time to first time occurrence of severe maternal adverse event since last menstruation period.Timepoint: The outcome will be assessed at interim midline (at one year) and endline (at two years).

Secondary

MeasureTime frame
Secondary outcomes will be event rates per 100 person months for each of adverse maternal outcomes & foetal outcomes.Timepoint: The outcome will be assessed at interim midline (at one year) & at endline (at two years).

Countries

India

Contacts

Public ContactShrey Desai

SEWA Rural

shrey.desai@sevarural.org9429109050

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026