A trial of a package for enhancing Fitness of Ante - And Post-Natal Women ?
Phase 3
- Conditions
- Health Condition 1: null- Pre and post natal women
- Registration Number
- CTRI/2018/02/012235
- Lead Sponsor
- PGIMER Chandigarh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 175
Inclusion Criteria
All pregnant women from the second trimester onward and those in postnatal stage till three months
Exclusion Criteria
1.Severe Cardiopulmonary disorder
2.Non cooperative patient
3.Any psychological abnormalities
4.Active vaginal bleeding
5.High fever
6.Any type of infection
7.Vaginal fistula
8.3rd and 4th degree uterine prolapse
9.Spinal cord injury
10.Threatened abortion or recurrent miscarriage
11.Previous premature births or history of early labor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method low & upper back Pain relief <br/ ><br>Leg cramps <br/ ><br>Incidence or severity of varicose vein Incidence of episiotomy done <br/ ><br>Improvement of muscle tone/power through MRC (Medical Research Council) method <br/ ><br>Improvement of body balance <br/ ><br>Body weight reduction (Obesity reduction) <br/ ><br>Time duration of recovery <br/ ><br>Rate of involution of uterus <br/ ><br>Rib pain/Thoracic pain/piriformis pain (VAS score ) <br/ ><br>Back/Shoulder/neck pain (VAS score ) <br/ ><br>Timepoint: Gestation period as per following details <br/ ><br>12-20 weeks <br/ ><br>28-32 weeks <br/ ><br>36- weeks till delivery <br/ ><br>Postnatal 1-10 days <br/ ><br>21- 30 days <br/ ><br>6-8 weeks <br/ ><br>12 weeks <br/ ><br>16 weeks <br/ ><br>20 weeks <br/ ><br>24weeks
- Secondary Outcome Measures
Name Time Method patient and caregiver satisfaction.Quality of lifeTimepoint: Gestation <br/ ><br>12-20 weeks <br/ ><br>28-32 weeks <br/ ><br>36- weeks till delivery <br/ ><br>Postnatal 1-10 days <br/ ><br>21- 30 days <br/ ><br>6-8 weeks <br/ ><br>12 weeks <br/ ><br>16 weeks <br/ ><br>20 weeks <br/ ><br>24 weeks <br/ ><br>