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Effect of combined intervention approach on utilization of full antenatal care and pregnancy outcome among pregnant women: A Cluster Randomized Controlled Trial

Effect of combined intervention approach on utilization of full antenatal care and pregnancy outcome among pregnant women: A Cluster Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/03/024281
Enrollment
1500
Registered
2020-03-26
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: 1- Obstetrics

Interventions

Intervention1: â??SAMPARKâ?? trial: â??SAMPARKâ?? includes Sensitization of high risk pregnancy, active involvement of community volunteers (Meri saheli), mobile app and system generated text messagin

Sponsors

AIIMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Pregnant woman aged 18-49 years. 2 Pregnant women whose husband or other family member have mobile phone. 3 Pregnant woman registering during first trimester of pregnancy will be eligible for enrollment. 4 Residents living in Uttrakhand and registered in eligible couple register

Exclusion criteria

Exclusion criteria: 1 Those who are not willing to participate/ providing informed written consent in the study. 2 Those who register after first trimester. 3 Seriously ill at the time of registration 4 Bad obstetric history

Design outcomes

Primary

MeasureTime frame
Primary outcome 1 Utilization of full ANC a 4 ANC visit b Consumption of 180 or more IFA tablets c 2 tetanus toxoid injection 2 Pregnancy outcome a Live birth (full term or preterm birth), b Stillbirth, c Spontaneous abortion and d Induced abortion Timepoint: At the time of delivery and after 42 days of delivery

Secondary

MeasureTime frame
Secondary outcome 1 Maternal health outcome a Maternal mortality rate b Hb level at birth c Institutional birth by skilled birth attendant d Timing of detection of high risk pregnancy 2 Type of delivery:- a Vaginal delivery b Assisted or operative delivery c Cesarean section 3 Neonatal health outcome a Thermal care b Early initiation of breast feeding within1 hours c At least one postnatal care visit within two days of birth d Birth weight Timepoint: At the time of delivery and after 42 days of delivery

Countries

India

Contacts

Public ContactMs Poonam Yadav

AIIMS, Rishikesh, Uttrakhand, India

drkantr2006@gmail.com9870717859

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026