PLUS: Push With Lower Uterine Segment Support
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Disimpaction with lower uterine support Cesarean section with support of the lower uterine segment |
Procedure: Cesarean 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
|
| Active Comparator: Classic push method Cesarean section with push method |
Procedure: Cesarean 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
|
Outcome Measures
Primary Outcome Measures
- Extension of uterine incision [During delivery of the fetus]
The incidence of extension of uterine incision
- Length of extension of uterine incision [During delivery of the fetus]
If extension of uterine incision happens, the length of extension will be measured
- Injury of the vagina [During delivery of the fetus]
Extension of uterine incision into the vagina
- Injury of the bladder [During delivery of the fetus]
Extension of uterine incision into the bladder
- Injury of the ureter [During delivery of the fetus]
Extension of uterine incision into the ureter
Secondary Outcome Measures
- Cesarean section operative time [Time from incision to closure of the skin (within 24 hours of recruitment)]
Duration of Cesarean section operation
- Intra-operative blood loss [During Cesarean section only]
Amount of blood loss as estimated by suction device from incision to closure of the skin
- The incidence of postpartum hemorrhage [During the first 24 hours post-operative]
Loss of more than 500 ml during the first 24 hours after surgery and the management that will be done
- Incidence of blood transfusion [During surgery and within the first 24 hours postoperative]
The incidence of blood transfusion due to significant blood loss (based on blood loss and clinical judgement "hypotension, tachycardia, pallor")
- Fetal traumatic birth injuries [During Cesarean section (fetal delivery)]
Skull fractures, limb fractures, brachial plexus injury, cephalhematoma, and subgaleal hematoma
- APGAR score [At 1 and 5 minutes after delivery of the newborn]
- Need for neonatal admission to neonatal intensive care unit [Within 24 hours of delivery of the newborn]
- Postoperative infections [1 week of postpartum]
Puerperal sepsis and Cesarean section wound infection
Eligibility Criteria
Criteria
Inclusion Criteria:
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Singleton term pregnancy, 37 to 42 weeks of gestation.
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Cephalic presentation.
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The cervix is fully dilated.
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Ruptured membranes.
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Adequate uterine contractions.
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Impacted fetal head in maternal pelvis
Exclusion Criteria:
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Intrauterine fetal death
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Major fetal anomalies
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Non-cephalic presentation
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Multiple pregnancy
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Preterm caesarean < 37 weeks
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Abnormal placentation.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Assiut University
- Aswan University
Investigators
- Study Director: Ahmed Nasr, MBBCh, MD, Assiut University
Study Documents (Full-Text)
None provided.More Information
Publications
- Dolea C, AbouZahr C. Global burden of obstructed labour in the year 2000. World Health Organization (WHO), Geneva, Switzerland. 2003 Jul;1:17.
- Landesman R, Graber EA. Abdominovaginal delivery: modification of the cesarean section operation to facilitate delivery of the impacted head. Am J Obstet Gynecol. 1984 Mar 15;148(6):707-10.
- Neilson JP, Lavender T, Quenby S, Wray S. Obstructed labour. Br Med Bull. 2003;67:191-204. Review.
- Shazly SA, Elsayed AH, Badran SM, Abdel Badee AY, Ali MK. Abdominal disimpaction with lower uterine segment support as a novel technique to minimize fetal and maternal morbidities during cesarean section for obstructed labor: a case series. Am J Perinatol. 2013 Sep;30(8):695-8. doi: 10.1055/s-0032-1331031. Epub 2012 Dec 27.
- PLUS-DIH-02