Intervention program to improve Quality of life among pregnant women who received infertility treatment.

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. - Nil

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/07/090401

Enrollment

120

Registered

2025-07-07

Start date

Unknown

Completion date

Unknown

Last updated

2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O090- Supervision of pregnancy with history of infertility

Interventions

Intervention1: 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 in

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
-Primary outcome of the study will be Improved quality of life Reduced stress and Reduced anxietyTimepoint: Follow up at 16, 24, 32 weeks of gestation, at 36 weeks of gestation and at the time of delivery delivery.	—

Secondary

Measure	Time frame
Secondary outcomes include successful pregnancy and neonatal outcome, good social support, increased knowledge and good acceptance of the Pregnancy Guidance and Support Program.Timepoint: Follow up at 16, 24, 32 weeks of gestation, at 36 weeks of gestation and after delivery	—

Countries

India

Contacts

Public ContactDr E Binu Margaret

Manipal College of Nursing,Manipal

binu.m@manipal.edu9844602532

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026