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CTRI Number  CTRI/2013/02/003441 [Registered on: 28/02/2013] Trial Registered Retrospectively
Last Modified On: 28/02/2013
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Trial 
Public Title of Study   Blood levels of a marker during pregnancy and its relation to the outcome of mother and child 
Scientific Title of Study   Serum homocysteine levels in late first trimester of pregnancy and its relation to maternal and fetal outcome  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mariano Mascarenhas 
Designation  Senior Resident 
Affiliation  JIPMER 
Address  Senior Resident, Department of Obstetrics and Gynaecology, JIPMER

Pondicherry
PONDICHERRY
605006
India 
Phone  9486197166  
Fax    
Email  docmariano@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Syed Habeebullah 
Designation  Professor and Head 
Affiliation  JIPMER 
Address  Department of Obstetrics and Gynaecology, JIPMER

Pondicherry
PONDICHERRY
605006
India 
Phone  9443413201  
Fax    
Email  oghod@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Mariano Mascarenhas 
Designation  Senior Resident 
Affiliation  JIPMER 
Address  11, Allwyn Nagar, Sungam Bypass Road, Coimbatore

Coimbatore
TAMIL NADU
641045
India 
Phone  9486197166  
Fax    
Email  docmariano@gmail.com  
 
Source of Monetary or Material Support  
JIPMER 
 
Primary Sponsor  
Name  JIPMER 
Address  Dhanvantri Nagar, Gorimedu, Pondicherry - 605 006, India 
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 
Mariano Mascarenhas  JIPMER  Dhanvantri Nagar, Gorimedu, Pondicherry - 605 006, India
Pondicherry
PONDICHERRY 
9486197166

docmariano@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JIPMER Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Healthy antenatal women at 8 to 12 weeks of gestation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Antenatal women between 8 to 12 weeks of gestation 
 
ExclusionCriteria 
Details  Known diabetics and hypertensives on treatment. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To correlate the levels of homocysteine in late first trimester of pregnancy (8-12 weeks) with the maternal and fetal outcome of pregnancy, especially with regard to development of hypertensive disorders of pregnancy and gestational diabetes mellitus.  July 2011 
 
Secondary Outcome  
Outcome  TimePoints 
To estimate the homocysteine levels in late 1st trimester (8-12 weeks) and to correlate it with prior history of (i)first, second, and third trimester pregnancy losses, (ii)hypertensive disorders of pregnancy and gestational diabetes mellitus, (iii)congenitally anomalous fetuses and (iv)preterm delivery and birth weight.  July 2011 
To correlate the homocysteine levels with the present pregnancy – parameters viz. (i)number of folic acid tablets ingested, (ii)hypertensive disorder of pregnancy and gestational diabetes mellitus, (iii)pregnancy loss, (iv)amniotic fluid volume and meconium staining of amiotic fluid,Iv)birth weight and (vi)type of delivery – spontaneous vaginal delivery, instrumental vaginal delivery or caesarean section  July 2011 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/08/2009 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Objective: To correlate the homocysteine levels in late first trimester of pregnancy with pregnancy outcome.

Study design: This was a follow up study comprising 100 antenatal women between 8 to 12 weeks of gestation. Serum homocysteine levels were checked after overnight fasting. Statistical analysis was done using unpaired t test for two parametrically distributed groups of data, Mann-Whitney U test for two non-parametrically distributed groups of data, one way ANOVA for more than two parametrically distributed groups of data and Kruskal-Wallis test for more than two non-parametrically distributed groups of data

Results: There were significantly elevated homocysteine levels among women with prior history of hypertensive disorders of pregnancy, and prior second or third trimester pregnancy losses. There was no significant difference in homocysteine levels among women with previous gestational diabetes mellitus, preterm deliveries or anomalous baby. Homocysteine levels were significantly elevated in those who developed hypertensive disorder of pregnancy, oligohydramnios, meconium stained amniotic fluid, had a pregnancy loss, or delivered a low birth weight baby. There was no significant difference in homocysteine levels for those who developed gestational diabetes mellitus. There was significant difference in homocysteine levels between those who had a spontaneous vaginal delivery, an instrumental vaginal delivery and a caesarean section.

Conclusions: Increased serum homocysteine levels in late first trimester are associated with history of pregnancy losses, hypertensive disorders of pregnancy and preterm birth and also associated with hypertensive disorders of pregnancy, pregnancy loss, oligohydramnios, meconium stained amniotic fluid and low birth weight in the current pregnancy.

 
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