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CTRI Number  CTRI/2020/10/028425 [Registered on: 15/10/2020] Trial Registered Prospectively
Last Modified On: 22/04/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   complications of tubal pregnanacy 
Scientific Title of Study   understanding of placentation in IVF preganancy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  keerthipriya 
Designation  junior resident 
Affiliation  kasturba medical college 
Address  DEPT. of obstetrics and gynecology,Kasturb a Hospital, Manipal, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9494745722  
Fax    
Email  keerthi.peramsetty@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anjali M 
Designation  Associate professor 
Affiliation  KMC,Manipal 
Address  Department of OBG KMC,Manipal

Udupi
KARNATAKA
576104
India 
Phone  9686448802  
Fax    
Email  anjali.suneel@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Anjali M 
Designation  Associate professor 
Affiliation  KMC,Manipal 
Address  Department of OBG KMC,Manipal

Udupi
KARNATAKA
576104
India 
Phone  9686448802  
Fax    
Email  anjali.suneel@manipal.edu  
 
Source of Monetary or Material Support  
kasturba medical college 
 
Primary Sponsor  
Name  KMC 
Address  DEPT. of obstetrics and gynecology,Kasturb a Hospital, Manipal, Karnataka 
Type of Sponsor  Private medical college 
 
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 Peramsetty Keerthipriya  kasturba medical college  Department of Obstetrics and Gynaecology Kasturba hospital,Manipal,Udipi District,Karnataka-576104
Udupi
KARNATAKA 		 9494745722

keerthi.peramsetty@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KMC INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O090||Supervision of pregnancy with history of infertility,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  all IVF pregnancy 
 
ExclusionCriteria 
Details  nil; 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
to study high risk pregnancy outcomes in ivf pregnancy  10 march 2020 to april 30th 2021 
 
Secondary Outcome  
Outcome  TimePoints 
complications in IVF pregnancies  10 march 2020 to april 30th 2021 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   15/10/2020 
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="0"
Months="10"
Days="10" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  		 nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  


  1. Title: Understanding of placentation in IVF pregnancies

 

  1. Type of Study: Prospective observational Study

 

  1. Aims & objectives:

●          To study complications in  IVF pregnancies

 

      4. Justification for study: To study relation of high risk pregnancy outcome in IVF pregnancies

 

       5. Departments involved: Department of Obstetrics and Gynecology

 

       6.  Study Period: march 2020  to April 2021

 

        7. Sample size: 150 

 

        8. Materials and methods:

8a.Inclusion criteria:

●          IVF pregnancies           

              8b.Exclusion criteria: nil

 

              8c. Biological materials:  placenta

       9 .   Detailed description of procedure / processes:

                   Women with IVF pregnancies will be collect the history/data of antenatal period                           associated with any high risk conditions like threatened abortions in first trimister, second trimester, fetal growth restriction, Gestational Diabetis mellitus, placental abnormalities. Post delivery weight of the placenta, weight of the baby, length of the cord will be check. Post delivery look for Maternal and Fetal complications related to placental function, placenta weight with pregnancy outcomes in IVF pregnancies.

 

 

               

 

 

10.Outcome measure:

                 To study complications in IVF pregnancies

 11.Potential risks and benefits: 

                 Minimal potential risks as it involves only collection of history, examination and investigations reports. If you take part in this study you may help other patients with knowledge of the condition

 

12.Ethical considerations and methods to address issues:

       An informed consent will be obtained from the participant after discussion about the whole procedure. IEC clearance obtained and use of hospital number as indirect identifier to ensure confidentiality

 

13.Budget (give details) and proposed funding source: No additional cost is required for this study.

 

14.Review of literature (within 1000 words): 

       IVF pregnancy can result in a high risk delivery.  The purpose of this study was to understand the reasons for the high risks in IVF deliveries.  If placental and infant weights at birth are higher in IVF pregnancy, the medical intervention rate and postpartum hemorrhage might be increased.  Fetal/placental  weight ratio in Ivf pregnancies found that inappropriately heavy placentas were found in female sex and in the nulliparity group and infants from pre eclampsia mothers group. Factors like maternal age , sex of the infant can influence placental size. There are reports of placental size being linked to complications of pregnancies such as diabetes, pregnancy induced hypertension. Maternal weight gain and prepregnancy maternal BMI may have contributing influence on placental weight even in the absence of diabetes.The micro array of tissue from the placenta showed that the expression of six factors involved in regulation of angiogenesis such as basic fibroblast growth factor and vascular endothelial growth factor receptor 3 was greater in the ART group than in natural pregnancy group.In complicated pregnancies associated with low birth weight, such as pregnancies with pre eclampsia or fetal death, a relative enlargement of the placenta when compared with fetal size has been seen.  Since ART pregnancies are at increased risk of complications, disproportions between placental weight and birth weight may be more common in these pregnancies.

 

15. References:

 

Birthweight and placental weight; do changes in culture media used for IVF matter? Comparisons with    spontaneous pregnancies in the corresponding time periods.

Anne Essklid 1,2,3 , Lars Monkerud4 . and Tom Tanbo5,*

 

Placental weight in singleton pregnancies technology: a population study of 536 567 pregnancies.

C. Haavaldsen 1,2,* , T. Tanbo 3 , and A. Esklid 1,2,4.

 

Mode of conception does not affect fetal or placental growth parameters or ratios in early gestation or a delivery

 Lauren W Sundheimer 1,2. jessica L Chan1. Rae Buttle1. Rosemarie Di Pentino1. Olivia Muramoto. Kerlly Castellano1. Erica T.Wang1,2.Jphn Williams III 2,3. Margareta D. Pisarska 1,2.

 

Difference in the size of the placenta and umbilical cord between women with natural pregnancy and those with IVF pregnancy.

Atsushi Yanaihara1. Shota Hatakeyama1. Shirei Ohgi1. Kenichirou Motomura1. Ryoma Taniguchi1. Aguri Hirano1. Shin Takenaka1. Takumi Yanaihara1.

 

 

 
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