Push With Lower Uterine Segment Support

Dystocia Clinical Trial

— PLUS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02934516
• Other study ID #: PLUS-DIH-02
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2020
• Est. completion date: August 2021

Study information

• Verified date: February 2020
• Source: Assiut University
• Contact: Sherif A. Shazly, MBBCh, MSc
• Phone: +15075131392
• Email: shazly.sherif2020[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: August 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dystocia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Assiut University	Aswan University

References & Publications (4)

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. — View Citation

Neilson JP, Lavender T, Quenby S, Wray S. Obstructed labour Reducing maternal death and disability during pregnancy. British medical bulletin. 2003 Dec 1;67(1):191-204.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extension of uterine incision	The incidence of extension of uterine incision	During delivery of the fetus
Primary	Length of extension of uterine incision	If extension of uterine incision happens, the length of extension will be measured	During delivery of the fetus
Primary	Injury of the vagina	Extension of uterine incision into the vagina	During delivery of the fetus
Primary	Injury of the bladder	Extension of uterine incision into the bladder	During delivery of the fetus
Primary	Injury of the ureter	Extension of uterine incision into the ureter	During delivery of the fetus
Secondary	Cesarean section operative time	Duration of Cesarean section operation	Time from incision to closure of the skin (within 24 hours of recruitment)
Secondary	Intra-operative blood loss	Amount of blood loss as estimated by suction device from incision to closure of the skin	During Cesarean section only
Secondary	The incidence of postpartum hemorrhage	Loss of more than 500 ml during the first 24 hours after surgery and the management that will be done	During the first 24 hours post-operative
Secondary	Incidence of blood transfusion	The incidence of blood transfusion due to significant blood loss (based on blood loss and clinical judgement "hypotension, tachycardia, pallor")	During surgery and within the first 24 hours postoperative
Secondary	Fetal traumatic birth injuries	Skull fractures, limb fractures, brachial plexus injury, cephalhematoma, and subgaleal hematoma	During Cesarean section (fetal delivery)
Secondary	APGAR score		At 1 and 5 minutes after delivery of the newborn
Secondary	Need for neonatal admission to neonatal intensive care unit		Within 24 hours of delivery of the newborn
Secondary	Postoperative infections	Puerperal sepsis and Cesarean section wound infection	1 week of postpartum