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Clinical Trials/CTRI/2024/04/065413
CTRI/2024/04/065413CompletedNot Applicable

Effectiveness of nipple stimulation technique in aiding spontaneous onset of labor in low risk primigravida

NA1 site in 1 country142 target enrollmentStarted: April 19, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
142
Locations
1
Primary Endpoint
To be observed in both groups in the form of maternal, fetal outcomes. Maternal outcomes such as change in the Bishop’s score after 2 weeks, spontaneous or induced labour, Induction for post-datism, mode of delivery, duration of labour and any hyperstimulation, meconium-stained liquor

Study Overview

Brief Summary

Low risk Primigravida who are at 37completed weeks of gestation, fitting the inclusion criteria will be recruited from the OPD during their routine antenatal visit to the hospital. A baseline cervical scoring using Bishop’s score will be done along with pelvic assessment and those with cephalopelvic disproportion will be excluded. These low risk pregnant women will be provided charts explaining the technique of nipple stimulation and its advantages as per

the consultant’s advice. The women who are consenting for the study will be taken as stimulation group and those are not willing for the study will be taken as non- stimulation group (each with sample size of 71). This nipple stimulation is a standard method of practice in some units, as it helps in cervical ripening and timely onset of labour without use of any pharmacological means. These women will be followed weekly in their regular weekly

antenatal follow up. No extra visits will be required for this study. They will be advised to keep a daily dairy of the manoeuvre and to be shown in the subsequent visit. At 39weeks, these women are to be followed up and those who has not done the manoeuvre will be excluded from the study. A repeat Bishop’s score has to be done at 39+ weeks of gestation, and changes in the cervical scoring to be noted in both the groups. These women will be

advised to attend immediately to the obstetric casualty in case of pain abdomen associated with tightening, leaking or bleeding PV or decreased fetal movements.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
20.00 Year(s) to 35.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • Low risk primigravida who completed 37weeks of gestation with cephalic presentation, and no other medical (such as diabetes, hypertension, hypothyroidism etc,) and surgical complications.

Exclusion Criteria

  • Those who have medical and surgical complications and other pregnancy related complications such as cephalo-pelvic disproportion, h/o assisted reproductive techniques and those who are not willing for the study.

Outcomes

Primary Outcomes

To be observed in both groups in the form of maternal, fetal outcomes. Maternal outcomes such as change in the Bishop’s score after 2 weeks, spontaneous or induced labour, Induction for post-datism, mode of delivery, duration of labour and any hyperstimulation, meconium-stained liquor

Time Frame: at the time of recruitment

Fetal outcomes such as Apgar score at 5 mins, requirement of neonatal intensive care unit admission, neonatal morbidities like sepsis, asphyxia, jaundice, respiratory distress, fetal or neonatal death.

Time Frame: at the time of recruitment

Secondary Outcomes

  • -(-)

Investigators

Sponsor
NA
Sponsor Class
Other [na]
Responsible Party
Principal Investigator
Principal Investigator

Dr. GEETHANJALI ADDALA

KMC, Manipal

Study Sites (1)

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