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CTRI Number  CTRI/2013/07/003799 [Registered on: 05/07/2013] Trial Registered Prospectively
Last Modified On: 07/04/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Treatment]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Oral Clindamycin during early pregnancy for prevention of preterm labor at community level 
Scientific Title of Study   Clindamycin to Reduce Preterm Birth in a Low Resource Setting: A Randomized Placebo-Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CCC#33043  Protocol Number 
NCT01800825  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr M B Bellad 
Designation  Professor 
Affiliation  J N Medical College 
Address  Professor Department of OBG J N Medical College Belgaum
Department of OBG J N Medical College Belgaum
Belgaum
KARNATAKA
590010
India 
Phone  8312474200  
Fax  8312472891  
Email  mbbellad@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr M B Bellad 
Designation  Professor 
Affiliation  J N Medical College 
Address  Professor Department of OBG J N Medical College Belgaum
Department of OBG J N Medical College Belgaum
Belgaum
KARNATAKA
590010
India 
Phone  8312474200  
Fax  8312472891  
Email  mbbellad@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr M B Bellad 
Designation  Professor 
Affiliation  J N Medical College 
Address  Professor Department of OBG J N Medical College Belgaum
Department of OBG J N Medical College Belgaum
Belgaum
KARNATAKA
590010
India 
Phone  8312474200  
Fax  8312472891  
Email  mbbellad@hotmail.com  
 
Source of Monetary or Material Support  
Christiana Care Health Services Inc 4755 Ogletown Stanton Rd Newark DE 19718 
 
Primary Sponsor  
Name  Thrasher Research Fund 
Address  68 S Main St Suite 400 Salt Lake City UT 84101  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr M B Bellad  KLE University, Jawaharlal Nehru Medical College  Department of OBGYN Jawaharlal Nehru Medical College
Belgaum
KARNATAKA 		 8312474200
8312472891
mbbellad@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Directorate of Health & Family Welfare Services, Government of Karnataka  Approved 
JNMC Institutional Ethics Committee on Human Subjects Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Pregnant Woman with Vaginal pH≥5 between 13 to 20 weeks, (1) ICD-10 Condition: O600||Preterm labor without delivery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Capsule Clindamycin 300 mg bd orally X 5 days  Intervention Arm: Capsule Clindamycin 300 mg bd orally X 5 days 
Comparator Agent  Capsule Placebo 1 bd orally X 5 days   Control Arm: Capsule Placebo 1 bd orally X 5 days  
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Women residing in the 12 study area clusters that present to the study PHCs/SCs for antenatal care (ANC) at 13 to 20 weeks gestation and provide cognizant written informed consent have no known sensitivity to antibiotics (clindamycin) and have singleton pregnancies are eligible for participation 
 
ExclusionCriteria 
Details  Women using antibiotics within the prior 14 days will be excluded from study
Symptomatic women will be excluded if they have received antibiotics within the prior 14 days (including the date of the ANC visit at which the participants pH is assessed 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
300 mg oral clindamycin twice daily for 5-days administered at 13-20 weeks of gestation to women with a vaginal pH≥5 will reduce the incidence of preterm delivery in women receiving placebo from 17.5% by 30%, e.g., to 12.25%,  at the time of delivery 
 
Secondary Outcome  
Outcome  TimePoints 
The oral clindamycin reduces the incidence of very preterm delivery (34 weeks), miscarriage, low birth weight (LBW, ≤2,500 grams), neonatal mortality rate (NMR) and either reduces or does not significantly affect the rates of maternal and neonatal complications through 42 days postpartum  at the time of delivery 
 
Target Sample Size   Total Sample Size="1600"
Sample Size from India="1600" 
Final Enrollment numbers achieved (Total)= "1726"
Final Enrollment numbers achieved (India)="1726" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/10/2013 
Date of Study Completion (India) 30/04/2016 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 30/04/2016 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Bellad MB, Hoffman MK, Mallapur AA, Charantimath US, Katageri GM, Ganachari MS, Kavi A, Ramdurg UY, Bannale SG, Revankar AP, Sloan NL, Kodkany BS, Goudar SS, Derman RJ. Clindamycin to reduce preterm birth in a low resource setting: a randomised placebo-controlled clinical trial. BJOG. 2018 May 22. doi: 10.1111/1471-0528.15290. PMID: 29790266 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Preterm delivery remains the largest cause of NMR, accounting for 27% of the 3.1 million annual deaths worldwide. Preterm delivery and gestational infection also are leading causes of the annual global 3.2 million stillbirths.  Maternal infection increases the incidence of and is responsible for 40% of spontaneous preterm deliveries making its prevention critical. The sole trials of oral clindamycin (including the double blind JNMC India trial) found 52% (p=0.004)15 and 62% (p=.036) lower rates of spontaneous and (in all, 35%, p=.19) births <37 weeks gestation in women receiving oral clindamycin at 13-21 weeks gestation. Both studies were relatively small, hospital-based. There has been a strong recommendation for a larger definitive trial. The intervention is affordable and scalable; if effective, it could avert 20,000 neonatal deaths in the study area and 232,500 worldwide. 
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