| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O720||Third-stage hemorrhage, |
|
|
Intervention / Comparator Agent
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [parvathinaik1@gmail.com].
- 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.
- 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. |