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Clinical Trials/CTRI/2024/10/075599
CTRI/2024/10/075599Not yet recruitingNot Applicable

Maternal and Fetal outcomes in preterm premature rupture of membranes- An Observational study At KLES Dr Prabhakar Kore Hospital and Medical College and Research Centre Belagavi

Dr.Nidhi Singh Badhoriya1 site in 1 country45 target enrollmentStarted: October 27, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
45
Locations
1
Primary Endpoint
To determine the maternal and fetal outcomes in cases of preterm premature rupture of membranes between gestational age of 28 weeks to 33 weeks 6 days

Study Overview

Brief Summary

Premature Rupture Of Membrane(PROM) is defined as the spontaneous rupture of fetal membranes prior to the onset of labor.

Membrane rupture before labor that occurs before 37 weeks of gestation is referred to as preterm pre-labor rupture of membranes.

PROM is one of the most challenging obstetric dilemma which occurs even in low risk pregnancies and can convert a traditional pregnancy into high risk nregnancy. Incidence of PROM at term is approximately 8% and pPROM is 3% of all pregnancies.pPROM (28weeks-33weeks 6 days) incidence is 1.45%

In developing countries, the incidence of PROM is about 18-20%

PROM is associated with 20% of neonatal deaths.

Management of PROM remains a matter of great debate till date.

Accurate prediction of maternal chorioamnionitis and early onset neonatal infections remains a critical challenge and is associated with increased neonatal morbidity and mortality.

Neonatal complications include early onset neonatal infections ,birth asphyxia, hyperbilirubinaemia , late onset sepsis , congenital pneumonia , bronchia-pulmonary dysplasia.

Incidence and prevalence of the above complications are not known in KLEs S Dr

Prabhakar Kore charitable Hospital and Medical Research Centre Belagavi.

Hence the study is being carried out to study the above mentioned complications and their incidence and prevalance

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 45.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 1.Pregnant women admitted with pPROM at more than or equal to 28 weeks to 33 weeks 6days period of gestation 2.Diagnosis of pPROM by.
  • Active pv leak on per speculum examination History of pv leak and on per speculum examination no leak present with usg suggestive of anamnios,severe oligohydramnios.

Exclusion Criteria

  • Intra uterine death.

Outcomes

Primary Outcomes

To determine the maternal and fetal outcomes in cases of preterm premature rupture of membranes between gestational age of 28 weeks to 33 weeks 6 days

Time Frame: 33 weeks 6 days

Secondary Outcomes

  • To determine the causes of preterm premature rupture of membranes(33 weeks 6 days)

Investigators

Sponsor
Dr.Nidhi Singh Badhoriya
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Nidhi Singh Badhoriya

KAHERs JAWAHARLAL NEHRU MEDICAL COLLEGE

Study Sites (1)

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