| CTRI Number |
CTRI/2023/02/049354 [Registered on: 01/02/2023] Trial Registered Prospectively |
| Last Modified On: |
06/05/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Improving care of women during pregnancy, delivery and the period after delivery in the government health system |
|
Scientific Title of Study
|
The Antenatal and Postnatal Care Research Collective (ARC): Antenatal, Intrapartum and
Postnatal Care: A Prospective, Longitudinal Study of Maternal and Newborn Health of the Pregnancy Risk
Stratification Innovation and Measurement Alliance (PRiSMA MNH Study) |
| Trial Acronym |
ARC |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sarmila Mazumder |
| Designation |
Senior Deputy Director and Senior Scientist |
| Affiliation |
Centre for Health Research and Development, Society for Applied Studies |
| Address |
Centre for Health Research and Development, Society for Applied
Studies 45 Kalu Sarai, New Delhi
South
DELHI
110016
India |
| Phone |
011-46043751-55 |
| Fax |
011-46043756 |
| Email |
sarmila.mazumder@sas.org.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarmila Mazumder |
| Designation |
Senior Deputy Director and Senior Scientist |
| Affiliation |
Centre for Health Research and Development, Society for Applied Studies |
| Address |
Centre for Health Research and Development, Society for Applied
Studies 45 Kalu Sarai, New Delhi
DELHI
110016
India |
| Phone |
011-46043751-55 |
| Fax |
011-46043756 |
| Email |
sarmila.mazumder@sas.org.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sarmila Mazumder |
| Designation |
Senior Deputy Director and Senior Scientist |
| Affiliation |
Centre for Health Research and Development, Society for Applied Studies |
| Address |
Centre for Health Research and Development, Society for Applied
Studies 45 Kalu Sarai, New Delhi
DELHI
110016
India |
| Phone |
011-46043751-55 |
| Fax |
011-46043756 |
| Email |
sarmila.mazumder@sas.org.in |
|
|
Source of Monetary or Material Support
|
| Christian Medical College, IDA Scudder Rd, Vellore, Tamil Nadu 632004 |
|
|
Primary Sponsor
|
| Name |
Centre for Health Research and Development Society for Applied Studies |
| Address |
45, Kalu Sarai, New Delhi |
| Type of Sponsor |
Other [Research Organization] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sarmila Mazumder |
Sub-Divisional Hospital, Hodal |
Sub-Divisional Hospital, Hodal, Palwal
Faridabad
HARYANA |
011-46043751-55
011-46043756
sarmila.mazumder@sas.org.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethics Review Committee, Centre for Health Research and Development, Society for Applied Studies |
Approved |
| Haryana State Government approvals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pregnant women |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
A pregnant woman who meets the following inclusion criteria may be enrolled at any stage of her pregnancy:
Women with confirmed pregnancy identified within the study catchment area through pregnancy surveillance and at study health facility |
|
| ExclusionCriteria |
| Details |
1. Decline to provide consent
2. Inability to provide informed consent
3. Less than 18 years of age
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Maternal Outcomes:
1. Maternal mortality & Severe maternal morbidity
2. Maternal anemia
Fetal and Neonatal outcomes
1. Stillbirth
2. 7-day neonatal mortality
3. 28-day neonatal mortality
4. Preterm birth
5. Low birth weight delivery
|
Maternal outcomes: During pregnancy, at delivery point and up to one-year post-delivery
Fetal and Neonatal outcomes: At the time of delivery or up to 28 days of birth |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Maternal outcomes and conditions
1. Late maternal mortality
2. Preeclampsia/ eclampsia
3. Antepartum and post-partum hemorrhage
4. Spontaneous preterm birth
5. Provider-initiated preterm birth
6. Preterm premature rupture of membranes (PPROM)
7. Indication for provider-initiated preterm birth (i.e., PPROM, fetal growth restriction, eclampsia)
8. Gestational diabetes
9. Maternal depression
10. Maternal sepsis
11. Other infections (e.g., chorioamnionitis)
|
During pregnancy, at delivery point and up to one-year post-delivery |
Fetal and newborn outcomes
1. Stillbirth (antepartum)
2. Stillbirth (intrapartum)
3. Early stillbirth (20 weeks or birthweight 500 g)
4. Newborn death
5. Small for gestational age
6. Hyperbilirubinemia
7. Neonatal sepsis or possible severe bacterial infection
8. Birth asphyxia (intrapartum-related complication)
|
At the time of delivery or up to 28 days of birth |
Quality of care indicators
1. Number of ANC visits
2. ANC visits 4 (%)
3. Gestational age (wks) at first ANC visit
4. Number of PNC visits
5. Facility birth (%)
6. Cesarean section rates (indication)
7. Time to reach facility (minutes)
8. Time to see provider (minutes)
9. Companion of choice (%)
10. Person-Centered Maternity Care scale
11. Satisfaction (%)
|
During pregnancy (ANC visits), at delivery point and up to one-year post-delivery |
|
|
Target Sample Size
|
Total Sample Size="2000"
Sample Size from India="2000"
Final Enrollment numbers achieved (Total)= "14271"
Final Enrollment numbers achieved (India)="14271" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2023 |
| Date of Study Completion (India) |
31/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="4"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
1. Sharma N, Rajitha P ET, Varghese S, Krishnamoorthy DK, Jadaun AS, Koshy RM, Vats P, Raj RB, Srinivasan R, Raghava Mohan V, Mazumder S. Cohort Profile: Hodal and Lowairpoa Demographic Surveillance Systems. Int J Epidemiol. 2025 Jun 11;54(4):dyaf099. doi: 10.1093/ije/dyaf099. PMID: 40671305; PMCID: PMC12267134.
2. Kotamreddy S, Srinivasan R, Sharma N, Jadaun AS, Pulimala E, Sasikumar M, Thankaraj S, Varghese S, Thiruvengadam R, Samuel P, Koshy RM, Mazumder S, Mathews JE, Bhatnagar S, Kang G, Mohan VR. Determinants of small vulnerable newborn births in two rural community-based cohorts in India: a prospective study. Lancet Reg Health Southeast Asia. 2026 Mar 2;47:100739. doi: 10.1016/j.lansea.2026.100739. PMID: 41799251; PMCID: PMC12961317. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The ARC study is
designed to reduce the risk of adverse pregnancy
outcomes through the following: 1) Increase the quality and quantity for ANC/IPC/PNC
services, 2) Improve risk prediction and management, 3) Ensure earlier initiation into ANC/IPC/PNC services, 4) Increase
the continuity of care across the continuum of care from ANC, IPC to PNC. The goals are
to develop a harmonized data set to improve our understanding of pregnancy risk
factors, vulnerabilities, and morbidity and mortality and to estimate the
burden of these risk factors and outcomes in LMICs. Ultimately, these data will
inform the development of innovative strategies to optimize pregnancy outcomes
for mothers and their newborns.
It will be
a prospective, open cohort study. All eligible pregnant women will be followed
through the antenatal, intrapartum and postnatal periods and infants through
one year of age
|