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Push With Lower Uterine Segment Support

Delivery of Impacted Fetal Head During Cesarean Section for Obstructed Labor: Push Method Versus Abdominal Disimpaction With Lower Uterine Segment Support

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02934516
Acronym
PLUS
Enrollment
66
Registered
2016-10-17
Start date
2020-05-31
Completion date
2021-08-31
Last updated
2020-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dystocia

Keywords

Obstructed labor, C section. push method, reverse breech

Brief summary

The study aims to compare maternal and early neonatal outcomes of abdominal disimpaction with lower uterine segment support in comparison to the classic push method for delivery of impacted fetal head during Cesarean section for obstructed labor.

Detailed description

Obstructed labor refers to failure of labor progress in spite of good uterine contractions and is attributed to mismatch between the size of the presenting part of the fetus and the mother's pelvis. Approximately 8% of maternal deaths worldwide are attributed to obstructed labor and subsequent puerperal infection, uterine rupture, and postpartum hemorrhage. In these situations, Cesarean section could minimize maternal and neonatal morbidity. However, Cesarean section is challenging when the head is deeply impacted and is associated with high risk of maternal injuries and perinatal injuries. The most common complication is extension of uterine incision which could involve the vagina, bladder, ureters and broad ligament. Neonates are also at risk of skull fractures, cephalhematoma, and subgaleal hematoma mainly due to manipulations. Currently, the most popular approaches for fetal head delivery are the push and pull methods. Although push method seems to be more convenient and does not necessitate extensive experience, it is more significantly associated with extension than the pull method. Although pull method seems to be more safe, it is more difficult to perform and usually warrants an aggressive uterine incision to deliver the fetus. In 2013, investigators published a case series on abdominal disimpaction with lower uterine segment support which basically allows obstetricians to deliver the fetal head through a transverse uterine incision with minimal risk of extensions and neonatal complications. In this study, investigators aim to validate this approach in comparison to the classic push method.

Interventions

PROCEDURECesarean section

Abdominal disimpaction with lower uterine segment support: the edge of the lower uterine segment is grasped by 3-4 modified Allies forceps (with broader jaws) applied along the lower edge of the incision until it is completely supported. These forceps are handled by the assistant, and gentle traction is applied upward, perpendicular to the uterine surface and away from the fetal head without excessive force. Accordingly, the hand of the surgeon could be inserted into the uterine cavity, and adequate space for manipulations is available without applying pressure on the lower segment. The fetal head is eventually grasped and delivered. Classic push method: delivering the head with assistance by pushing the fetal head vaginally

Sponsors

Aswan University
CollaboratorOTHER
Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* Singleton term pregnancy, 37 to 42 weeks of gestation. * Cephalic presentation. * The cervix is fully dilated. * Ruptured membranes. * Adequate uterine contractions. * Impacted fetal head in maternal pelvis

Exclusion criteria

* Intrauterine fetal death * Major fetal anomalies * Non-cephalic presentation * Multiple pregnancy * Preterm caesarean \< 37 weeks * Abnormal placentation.

Design outcomes

Primary

MeasureTime frameDescription
Extension of uterine incisionDuring delivery of the fetusThe incidence of extension of uterine incision
Length of extension of uterine incisionDuring delivery of the fetusIf extension of uterine incision happens, the length of extension will be measured
Injury of the vaginaDuring delivery of the fetusExtension of uterine incision into the vagina
Injury of the bladderDuring delivery of the fetusExtension of uterine incision into the bladder
Injury of the ureterDuring delivery of the fetusExtension of uterine incision into the ureter

Secondary

MeasureTime frameDescription
APGAR scoreAt 1 and 5 minutes after delivery of the newborn
Cesarean section operative timeTime from incision to closure of the skin (within 24 hours of recruitment)Duration of Cesarean section operation
Postoperative infections1 week of postpartumPuerperal sepsis and Cesarean section wound infection
Need for neonatal admission to neonatal intensive care unitWithin 24 hours of delivery of the newborn
Intra-operative blood lossDuring Cesarean section onlyAmount of blood loss as estimated by suction device from incision to closure of the skin
The incidence of postpartum hemorrhageDuring the first 24 hours post-operativeLoss of more than 500 ml during the first 24 hours after surgery and the management that will be done
Incidence of blood transfusionDuring surgery and within the first 24 hours postoperativeThe incidence of blood transfusion due to significant blood loss (based on blood loss and clinical judgement hypotension, tachycardia, pallor)
Fetal traumatic birth injuriesDuring Cesarean section (fetal delivery)Skull fractures, limb fractures, brachial plexus injury, cephalhematoma, and subgaleal hematoma

Contacts

Primary ContactSherif A. Shazly, MBBCh, MSc
shazly.sherif2020@gmail.com+15075131392
Backup ContactAmr Shehata, MBBCh, MD
Love_like902@Yahoo.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026