Comparative clinical study on the effectiveness of Yoni Lepa with Apamarga Vasa gel and dinoprostone gel in first stage of labour
Overview
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Spontaneous onset of labour pain with progress and reduced duration of first stage of labour
Overview
Brief Summary
This study is a single blind double arm comparative clinical trial to evaluate the possible effect of Apamarga Vasa moola yoni lepa in first stage of labour and to compare its possible effect with Dinoprostone Gel.
This study will be conducted at Inpatient department of Prasuti tantra and Stree roga at Sri Dharmasthala Manjunatheshwara ayurveda hospital, Hassan, Karnataka.
Methods:
During the latent phase of labour- Trial group- 20ml Apamarga Vasa gel will be applied to the posterior fornix at interval of 4 hours.
Control group- dinoprostone gel 0.5mg will be applied to the posterior fornix at interval of 4 hours.
Maximum 3 doses in both groups
Assessment of progress of labour will be done with bishop’s score and partograph in both groups.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 20.00 Year(s) to 30.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •1.subject who fulfill the diagnostic criteria 2.single intrauterine gestation with vertex presentation 3.subject who are agree to participate and ready to sign the consent form.
Exclusion Criteria
- •1.High risk pregnancy with hypertensive disorders, gestational diabetes mellitus, pulmonary disease, renal disease, psychiatric illness, cardiac disease, epilepsy, severe anemia 2.Diagnosed with HIV, HBsAg, and VDRL 3.Absolutevindication of caesarean section.
Outcomes
Primary Outcomes
Spontaneous onset of labour pain with progress and reduced duration of first stage of labour
Time Frame: Assessment will be done at baseline and once in every 4 hours using bishops score and partograph.
Secondary Outcomes
- delivery of a live baby(Approximate 12 hours of onset of labour pain.)
Investigators
Dr Bharti Yadav
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan