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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: CTRI
Last refreshed on: 24 November 2021
Main ID:  CTRI/2015/11/006347
Date of registration: 06-11-2015
Prospective Registration: Yes
Primary sponsor: Deepthi Varghese
Public title: can early breast feeding reduce pain after normal or caesarean delivery ?
Scientific title: Impact of breast feeding on postpartum pain after vaginal and caesarean delivery among the multiparous women in a selected hospital
Date of first enrolment: 07-12-2015
Target sample size: 70
Recruitment status: Open to Recruitment
URL:  http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=12293
Study type:  Observational
Study design:  Single Arm Trial
Method of generating randomization sequence:Adaptive randomization, such as minimization Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
 
Phase:  N/A
Countries of recruitment
India
Contacts
Name: Savitha Pramilda Cutinho   
Address:  Professor Department of OBG Nursing Father Muller College of Nursing Kankanady Mangalore Professor Department of OBG Nursing Father Muller College of Nursing Kankanady Mangalore 575002 Dakshina Kannada, KARNATAKA India
Telephone: 9740687444
Email: savithacutinho@hotmail.com
Affiliation:  Father Muller College of Nursing
Name: Brincy DSouza   
Address:  Department of Paediatric Nursing Father Muller College of Nursing Kankanady Department of Paediatric Nursing Father Muller College of Nursing Kankanady 575002 Dakshina Kannada, KARNATAKA India
Telephone: 9740687444
Email: savithacutinho@hotmail.com
Affiliation:  Father Muller College of Nursing
Key inclusion & exclusion criteria
Inclusion criteria: Multiparous women with

Age above 18 years

Term gestation (more than 37 weeks of gestation)

Prior breastfeeding experience at least with 1 baby

Lactating mothre

Normal vaginal delivery with episiotomy after 12 hours

Lower segmented cesarean delivery after 24 hours

Singleton delivery.


Exclusion criteria: Multiparous women with

Chronic pain

Substance abuse

Classical cesarean incision

Not planning to breastfeed

Psychiatric or cognitive disorders like anxiety or depression

Twins



Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
Intervention(s)
Control Intervention1: Impact of cesarean incision pain: Pain due cesarean incision. Pain which occurred after delivery. The wound will be sutured in layers and takes few days to heal.
Control Intervention2: Impact of pain due to episiotomy during normal delivery: Epistolary is a type incision in perineal area for easy delivery of baby s head and after delivery wound will be sutured .It will take few days to heal.
Control Intervention3: Cramping pain: Intermittent pain in the lower abdomen occurred 5 minutes before ,during and 5 minutes after breast feeding.
Control Intervention4: Breast Feeding: A neonate sucking from mothers breast after 6-12 hrs after vaginal delivery and 24 hours after cesarean delivery
Primary Outcome(s)
To determine the impact of breastfeeding on incisional, perineal and cramping pain after cesarean and vaginal deliveryTimepoint: 3 days
Secondary Outcome(s)
To make the women aware about their postnatal pains and healthy side effects on the uterus to help in involutionTimepoint: 1 month
Secondary ID(s)
NIL
Source(s) of Monetary Support
Father Muller Medical College Hospital FMCI Kankanady Mangalore 575002
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 18/02/2015
Contact:
Father Muller Institutional Ethics Committee
Results
Results available:
Date Posted:
Date Completed:
URL:
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