| CTRI Number |
CTRI/2025/07/090401 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
05/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Intervention program to improve Quality of life among pregnant women who received infertility treatment. |
|
Scientific Title of Study
|
Effectiveness of Pregnancy Guidance and Support Program (PreG-SupP) on quality of life, stress, and anxiety among pregnant women who received infertility treatment in a selected hospital of Kannur district, Kerala- a Randomized Controlled Trial. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shelmi Antony |
| Designation |
Professor, PhD Scholar |
| Affiliation |
Koyili College of Nursing Kannur;Manipal College of Nursing Manipal |
| Address |
Department of OBG Nursing,First floor,Room No:1
Koyili College of Nursing Kannadiparamba PO kannur
Kannur
KERALA
670604
India |
| Phone |
9400213852 |
| Fax |
|
| Email |
antonyshelmi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr E Binu Margaret |
| Designation |
Assistant Professor Selection Grade |
| Affiliation |
Manipal College of Nursing,Manipal |
| Address |
Assistant Professor Selection Grade
Cabin 2 First floor
Department of Child Health Nursing
Manipal College of Nursing Manipal MAHE
Udupi
KARNATAKA
576104
India |
| Phone |
9844602532 |
| Fax |
|
| Email |
binu.m@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr E Binu Margaret |
| Designation |
Assistant Professor Selection Grade |
| Affiliation |
Manipal College of Nursing,Manipal |
| Address |
Assistant Professor Selection Grade
Cabin 2 First floor
Department of Child Health Nursing
Manipal College of Nursing Manipal MAHE
Udupi
KARNATAKA
576104
India |
| Phone |
9844602532 |
| Fax |
|
| Email |
binu.m@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Koyili Resmi IVF Centre, Koyili Hospital,First floor Pallikunnu po, Kannur, Pincode- 670004
Kerala ,India |
|
|
Primary Sponsor
|
| Name |
SHELMI ANTONY |
| Address |
Koyili College of Nursing Kannnadiparamba po, Kannur Pincode 670604,Kerala, India |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Shelmi Antony DrJoselin Mariet M |
Resmi clinic,Koyili hospital |
IVF Clinic, First floor Pallikunnu po Kannur
670004
Kannur
KERALA |
9400213852
joselinmariet73@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Govt Ayurveda College Kannur, Pariyaram |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
| Intervention |
Pregnancy Guidance and Support Program (PreG-SupP) |
The PreG-SupP is a comprehensive educational and counselling intervention program aimed at supporting the pregnant women following infertility treatment to enhance the quality of life and mental health during pregnancy and improve the pregnancy and neonatal outcomes. It is an individual face-to-face counselling and teaching program delivered by the primary investigator who is a certified counsellor and an expert in the area.
Pregnancy Guidance and Support Program (PreG-SupP) will be delivered in 8 sessions, including five counseling sessions, 3 comprehensive educational sessions covering antenatal care and relaxation techniques.
Time I/Phase I Intervention.
Session I
during 8 – 10 weeks of gestation including counselling for the participants and partner and the first phase of comprehensive educational program on antenatal care during first trimester
Time 2/ Phase II Intervention:
Session 2 during 12 – 13 weeks of gestation including second phase of counselling and 2nd phase of Comprehensive education program on antenatal care during second trimester
and teaching on relaxation techniques.
Time 3 / Phase III Intervention:
session 3 at 16 weeks of gestation is the third phase of counselling
Time 4/ Phase IV Intervention:
at 20 weeks of gestation is the fourth phase of counselling
Time 5/Phase V Intervention:
at 24 weeks of gestation is the Fifth Phase of Counseling and third phase of comprehensive educational program covering antenatal care during third trimester
-Preparation for labor
-Breastfeeding and
-Care of newborn
Follow up once in two weeks
through Online or Telephonic follow-up
|
| Comparator Agent |
Standard care |
The comparator group will receive standard care which refers to the routine care of a pregnant women followed by the infertility treatment from the infertility clinic by the health care professionals during their regular follow up. It includes routine antenatal visits, monitoring of fetal well-being, screening or detection of high risk pregnancies, and advice on nutrient supplementation and medications during pregnancy. |
|
|
Inclusion Criteria
|
| Age From |
24.00 Year(s) |
| Age To |
44.00 Year(s) |
| Gender |
Female |
| Details |
24-33 years: 6 blocks with block size 10 (5 each in intervention & control arm) (n=60)
33-44 years: 6 blocks with block size 10 (5 each in intervention & control arm) (n=60)
-with a period of gestation 8 – 10 weeks, having confirmed pregnancy with cardiac activity after the primary infertility treatment with In Vitro Fertilization visiting the Reshmi Infertility Clinic, a unit of Koyili Hospital, Kannur District, Kerala.
-Who will come for regular follow-up in the Reshmi Infertility Clinic, Kannur
-Who are willing to participate in the study and give consent.
-Know to read and speak Malayalam or English.
|
|
| ExclusionCriteria |
| Details |
Pregnant women with severe chronic medical conditions like pre-existing cardiovascular respiratory or renal diseases blood disorders multiple pregnancies history of psychiatric illness
Who have undergone structured psychological intervention over the past 6 months or more than 5 sessions
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| - Primary outcome of the study will be Improved quality of life Reduced stress and Reduced anxiety |
Follow up at 16, 24, 32 weeks of gestation, at 36 weeks of gestation and at the time of delivery delivery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • Secondary outcomes include successful pregnancy and neonatal outcome, good social support, increased knowledge and good acceptance of the Pregnancy Guidance and Support Program. |
Follow up at 16, 24, 32 weeks of gestation, at 36 weeks of gestation and after delivery |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Infertility impacts a significant portion of the population at some stage in their lives. The existing literature gave insight into the need for assessment of mental health of pregnant women following infertility treatment. Only limited studies have focused on quality of life among the pregnant women following infertility treatment. There are studies done among pregnant women who conceived spontaneously. The existing literature revealed that the pregnant women following infertility treatment are more stressed, anxious about pregnancy, and the health of their baby and they require extra support during their pregnancy. The purpose of this study is to evaluate how effective is the Pregnancy Guidance and Support Program (PreG-SupP) in improving the quality of life and reducing stress and anxiety of pregnant women who conceived through IVF and to have better maternal and neonatal outcomes. The study also aimed to empower mothers about antenatal care, how to manage the difficulties encountered due to physical and physiological changes during pregnancy and how to prepare better for childbirth.
HYPOTHESES All the hypotheses will be tested at 0.05 level of significance. H1: There will be significant difference in the quality-of-life scores among pregnant women who received infertility treatment between the intervention and control group. H2: There will be significant difference in the stress scores among pregnant women who received infertility treatment between the intervention and control group. H3: There will be significant difference in the anxiety scores among pregnant women who received infertility treatment between the intervention and control group. H4: There will be significant difference in the social support scores among pregnant women who received infertility treatment between the intervention and control group. H5: There will be significant difference in the pregnancy and neonatal outcomes among pregnant women who received infertility treatment between the intervention and control group.
|