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DystociaPLUSNCT02934516

Push With Lower Uterine Segment Support

A study testing Cesarean section in people with Dystocia, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 40 years, women only
Conditions the study is for
Dystocia
What is being tested?
Cesarean section
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
No sites listed yet
Study dates
May 2020to Aug 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

No sites are listed yet.

Sherif A. Shazly, MBBCh, MSc contact

+15075131392

shazly.sherif2020@gmail.com

Amr Shehata, MBBCh, MD contact

Love_like902@Yahoo.com

About this study

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

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.

Read the 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.

Conditions
Dystocia
Being tested
Cesarean section
Keywords
Obstructed labor, C section. push method, reverse breech
Medical subject headings
Dystocia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cesarean sectionProcedure or surgery

    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

Study groups in NCT02934516
Study groupRoleWhat they receive
Disimpaction with lower uterine supportExperimentalCesarean section with support of the lower uterine segment
Receives: Procedure: Cesarean section
Classic push methodActive comparatorCesarean section with push method
Receives: Procedure: Cesarean section

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Extension of uterine incision

    The incidence of extension of uterine incision

    Measured: During delivery of the fetus

  2. Length of extension of uterine incision

    If extension of uterine incision happens, the length of extension will be measured

    Measured: During delivery of the fetus

  3. Injury of the vagina

    Extension of uterine incision into the vagina

    Measured: During delivery of the fetus

  4. Injury of the bladder

    Extension of uterine incision into the bladder

    Measured: During delivery of the fetus

  5. Injury of the ureter

    Extension of uterine incision into the ureter

    Measured: During delivery of the fetus

Secondary outcomes (8)

  1. Cesarean section operative time

    Duration of Cesarean section operation

    Measured: Time from incision to closure of the skin (within 24 hours of recruitment)

  2. Intra-operative blood loss

    Amount of blood loss as estimated by suction device from incision to closure of the skin

    Measured: During Cesarean section only

  3. 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

    Measured: During the first 24 hours post-operative

  4. Incidence of blood transfusion

    The incidence of blood transfusion due to significant blood loss (based on blood loss and clinical judgement "hypotension, tachycardia, pallor")

    Measured: During surgery and within the first 24 hours postoperative

  5. Fetal traumatic birth injuries

    Skull fractures, limb fractures, brachial plexus injury, cephalhematoma, and subgaleal hematoma

    Measured: During Cesarean section (fetal delivery)

  6. APGAR score

    Measured: At 1 and 5 minutes after delivery of the newborn

  7. Need for neonatal admission to neonatal intensive care unit

    Measured: Within 24 hours of delivery of the newborn

  8. Postoperative infections

    Puerperal sepsis and Cesarean section wound infection

    Measured: 1 week of postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2016 (estimated)
  2. Study startMay 2020 (estimated)
  3. Primary completionApr 2021 (estimated)
  4. Study completionAug 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02934516
Sponsor's protocol ID
PLUS-DIH-02
Acronym
PLUS
Status last verified
Feb 2020
First submitted
13 Oct 2016
Last updated
28 Feb 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dolea C, AbouZahr C. Global burden of obstructed labour in the year 2000. World Health Organization (WHO), Geneva, Switzerland. 2003 Jul;1:17.

  • Neilson JP, Lavender T, Quenby S, Wray S. Obstructed labour. Br Med Bull. 2003;67:191-204. doi: 10.1093/bmb/ldg018.

    PubMed 14711764

  • 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. doi: 10.1016/0002-9378(84)90551-9.

    PubMed 6702937

  • 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.

    PubMed 23271386

Questions about this trial

What is this clinical trial studying?

A study testing Cesarean section in people with Dystocia, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sherif A. Shazly, MBBCh, MSc (+15075131392, shazly.sherif2020@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Extension of uterine incision (time frame: During delivery of the fetus). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02934516, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2020.

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