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Clinical Trials/NCT04813237
NCT04813237
Unknown
Not Applicable

Clinical Implications of Fetal Positioning During Delivery

Żelazna Medical Centre, LLC1 site in 1 country300 target enrollmentMarch 31, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fetal Position and Presentation Abnormalities
Sponsor
Żelazna Medical Centre, LLC
Enrollment
300
Locations
1
Primary Endpoint
Mode of delivery
Last Updated
5 years ago

Overview

Brief Summary

The project aims to find a relationship between the positioning of the foetus before and during birth and the results of obstetrics and to determine their incidence in the Polish population. The study will be conducted by combining the use of ultrasound diagnostics, midwives observations during childbirth, analysis of medical documentation and a questionnaire on the activity of examined women. The obtained results will be used to prepare guidelines for the birth in a particular foetus position.

Detailed Description

The purpose of the examination is to describe the difficulties associated with delivery in a non-optimal position of the fetus. Initial observations show that such childbirth is perceived as difficult by both the women giving birth and the staff. The aim of the study is to describe the level of difficulty of this labor, expressed as the experience of the woman, as well as all the elements that may affect the difficulty of this labor, for example, slower or no progress in labor, disturbances in systolic function, injuries, the need to use epidural anesthesia, increased blood loss.

Registry
clinicaltrials.gov
Start Date
March 31, 2021
End Date
December 30, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Żelazna Medical Centre, LLC
Responsible Party
Principal Investigator
Principal Investigator

Barbara Baranowska

Assistant at Maternity Ward St. Sophia Specialst Hospital in Warsaw, Principal Investigator

Żelazna Medical Centre, LLC

Eligibility Criteria

Inclusion Criteria

  • during childbirth,
  • in a single pregnancy,

Exclusion Criteria

  • pelvic position of the fetus
  • in whom labor is induced for reasons other than post-term pregnancy,
  • women who came to the hospital in the second stage of labor
  • severe diseases mother or foetus.

Outcomes

Primary Outcomes

Mode of delivery

Time Frame: immediately after delivery

Mode of delivery as measured by number of women who had a vaginal, instrumental or operational delivery.

Secondary Outcomes

  • Blood loss(immediately after delivery)
  • Difficulty of childbirth(immediately after delivery)
  • Duration of delivery(immediately after birth)
  • Uterine contractions(during birth)
  • Episiotomy(immediately after delivery)
  • Methods of placental separation(immediately after delivery)
  • Labor progress(during birth)
  • Epidural(immediately after delivery)
  • Perineum injury(immediately after delivery)

Study Sites (1)

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