Comparison of Prevention and Appropiate Obstetric Interventions for Prolonged Second Stage Labor at Term Pregnancies During Vaginal Delivery

NCT04888871 | Unknown

• 1 other identifier: 2020/123
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized Control Trial for Comparison of Prevention and Appropiate Obstetric Interventions for Prolonged Second Stage Labor at Term Pregnancies During Vaginal Delivery.

Conditions

Vacuum Extraction; Failure, Affecting Fetus or Newborn; Obstetric Labor Complications; Complicated Labour/Delivery Livebirth

Keywords

labor stage, second

Outcome Measures

Primary Outcomes (1)

• maternal morbidity

  3 months

Study Arms (3)

Only Fundal Pressure (Kristeller Maneuver)

prolonged second stage phase and not prolonged second phase in pregnant women to singletons at the weeks between 37-42, applying Only Fundal Pressure (Kristeller Maneuver) and the postpartum evaluation of maternal episiotomy needs presence of second and third degree perineal tears, presence of postpartum hemorrhage and need for blood transfusion , cesarean rates and fetal first and fifth minute Apgar score , fetal blood gas parameters, presence of fetal trauma, need for neonatal intensive care will

Only Vacuum Extraction

prolonged second stage phase and not prolonged second phase in pregnant women to singletons at the weeks between 37-42, applying only vacuum extraction and the postpartum evaluation of maternal episiotomy needs presence of second and third degree perineal tears, presence of postpartum hemorrhage and need for blood transfusion , cesarean rates and fetal first and fifth minute Apgar score , fetal blood gas parameters, presence of fetal trauma, need for neonatal intensive care will

Both Fundal Pressure (Kristeller Maneuver) and Vacuum Extraction

prolonged second stage phase and not prolonged second phase in pregnant women to singletons at the weeks between 37-42, applying Both Fundal Pressure (Kristeller Maneuver) and Vacuum Extraction and the postpartum evaluation of maternal episiotomy needs presence of second and third degree perineal tears, presence of postpartum hemorrhage and need for blood transfusion , cesarean rates and fetal first and fifth minute Apgar score , fetal blood gas parameters, presence of fetal trauma, need for neonatal intensive care will

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Randomized Control Trial for Comparison of Prevention and Appropiate Obstetric Interventions for Prolonged Second Stage Labor at Term Pregnancies During Vaginal Delivery.

You may qualify if:

• term pregnancy weeks between 37-42, singleton, vertex presentations
• prolonged second stage of labor
• Fetal head is minimum at the level of ischial spin
• maternal incompatibility during/after second stage of labor
• complete cervical dilatation

You may not qualify if:

• Fetal distress
• Uncomplete cervical dilatation
• twin pregnancies or polycyesia
• Pregnancy weeks lower than 37weeks
• other than vertex presentations
• Fetal Anomalies

Sponsors & Collaborators

• Zeynep Kamil Maternity and Pediatric Research and Training Hospital: lead

Study Sites (1)

Zeynep Kamil Maternity and Childrens Hospital

Istanbul, Uskudar, 34660, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Obstetric Labor Complications; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 17, 2021
• Study Start: February 1, 2020
• Primary Completion: August 1, 2020
• Study Completion: May 31, 2021
• Last Updated: May 17, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)