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CTRI Number  CTRI/2022/03/041333 [Registered on: 24/03/2022] Trial Registered Prospectively
Last Modified On: 23/03/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   comparison of time taken for placental delivery and complications following delivery of the baby in IVF pregnancies 
Scientific Title of Study   Comparison of Third stage complications between fresh and frozen embryo transfer pregnancies - An analytical Cohort study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Reema Thapa Magar 
Designation  PG student 
Affiliation  JIPMER 
Address  Department of Obstetrics & Gynaecology, Women and Children Hospital

Pondicherry
PONDICHERRY
605006
India 
Phone  9486274844  
Fax    
Email  reenasme42@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  T Parvathi 
Designation  Assistant Professor 
Affiliation  JIPMER 
Address  Department of Obstetrics & Gynecology Women and Child Hospital 1st floor ICMR research lab JIPMER Dhanavanthri Nagar

Pondicherry
PONDICHERRY
605006
India 
Phone  09566537193  
Fax    
Email  parvathinaik1@gmail.com  
 
Details of Contact Person
Public Query
 
Name  T Parvathi 
Designation  Assistant Professor 
Affiliation  JIPMER 
Address  Department of Obstetrics & Gynecology Women and Child Hospital 1st floor ICMR research lab JIPMER Dhanavanthri Nagar

Pondicherry
PONDICHERRY
605006
India 
Phone  09566537193  
Fax    
Email  parvathinaik1@gmail.com  
 
Source of Monetary or Material Support  
Department of Obstetrics & Gynaecology JIPMER Pondicherry 
 
Primary Sponsor  
Name  JIPMER 
Address  Department of Obstetrics & and Gynaecology WCH Dhanavanthri Nagar JIPMER PONDICHERRY  
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 
T Parvathi  JIPMER  Department of Obstetrics & Gynecology Women and Child Hospital 1st floor ICMR research lab JIPMER Dhanavanthri Nagar
Pondicherry
PONDICHERRY 
09566537193

parvathinaik1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee JIPMER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O720||Third-stage hemorrhage,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  1. Pregnant women ≥ 18 years of age
2. Conceived following frozen/fresh embryo transfer
3. Gestational age ≥28 weeks
 
 
ExclusionCriteria 
Details  1. Uterine Anomalies
2. History of Manual removal of placenta
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Duration of third stage
Retained placenta
Manual removal of Placenta
Adherent placenta
Postpartum haemorrhage
Peripartum hysterectomy
Need for Blood transfusion
Admission to the intensive care unit
 
Time following delivery of baby to placental delivery 
 
Secondary Outcome  
Outcome  TimePoints 
Factors associated with third stage complications  Antenatal period, intrapartum and postpartum till placental delivery 
 
Target Sample Size   Total Sample Size="337"
Sample Size from India="337" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   28/03/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [parvathinaik1@gmail.com].

  6. For how long will this data be available start date provided 01-01-2024 and end date provided 01-01-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  

The third stage of Labour begins from the delivery of the baby to the expulsion of the placenta and membranes. There are 3 distinct phases of the Third stage of labour; strong uterine muscle contraction, expulsion phase and uterine vessel contraction phase. Active management of the third stage of labour(AMTSL) is advocated as a prophylactic measure to decrease the postpartum haemorrhage.

 Globally, there is an increase in the utilisation of Assisted Reproductive Technologies (ART) among infertile couples. Similar growth in ART clinics and cycles has been recorded in India as per the National ART registry. With advances in the quality and efficacy of the techniques, the conception rate following ART (OI, IUI, IVF, ICSI) has increased significantly. The high prevalence of multiple pregnancies being most commonly associated with these techniques increases adverse maternal and perinatal outcomes. Most of the retrospective cohort studies have observed similar complications even in singleton pregnancy following ART as compared to spontaneous conceptions. 

 Most of the previous literature has focussed on composite adverse pregnancy outcomes in these conceptions. From the previous studies, it has been shown that ART is associated with increased third stage complications like increased duration, morbidly adherent placenta, and manual removal of placenta, PPH, blood transfusion and ICU admission.

There is a lacuna in Indian data with respect to third stage outcomes specific to various ART.

If the study results show specific complications with regard to techniques, a focused approach for predicting third stage complications can be advocated to prevent morbidity and mortality.

 
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