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

Z

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Status

Unknown

Conditions

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

Study type

Observational

Funder types

Other

Identifiers

NCT04888871
2020/123

Details and patient eligibility

About

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

Full description

This study includes prolonged second stage phase and not prolonged second phase in pregnant women to singletons at the weeks between 37-42. Fetal head level will be at or below the ischial spines in all patients.Patients with fully dilated cervix will be included in the study and the bladder will be emptied completely on the labor table. Patients diagnosed with fetal distress will not be included in the study.Indicated patients will be randomly divided into three groups; one group will be only subjected to a Fundal Pressure (Kristaller Maneuver), second group will only be subjected to Vacuum Extraction and the third group will be subjected to both Fundal Pressure (Kristaller Maneuver) and Vacuum Extraction. 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 be evaluated among three randomized groups.

Enrollment

150 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

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

Trial design

150 participants in 3 patient groups

Only Fundal Pressure (Kristeller Maneuver)
Description:
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
Description:
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
Description:
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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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