Health TrialsbyHealthPanel

Simplified Conservative Measures in Managing Morbidly Adherent Placenta in Beni-Suef University

ConditionPlacenta Accreta
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25-45
SponsorNesreen Abdel Fattah Abdullah Shehata

About this trial

To evaluate the efficacy of modified uterine artery ligation and myometrial compression as a conservative measure in improving the prognosis of the morbidly adherent placenta.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Gestational age more than 28 weeks as determined by LMP and ultrasound.

Placenta previa as confirmed by ultrasound.

Clinically stable with no or mild vaginal bleeding.

No evidence of fetal compromise.

Disqualifiers

Vaginal bleeding

Medical disorders

Trial design

Design model

Parallel

Treatments tested in this trial

  • O, lreay suture

    Procedure/Surgery

    bilateral uterine artery ligations as described by O- lreay technique in addition to standard conservative methods. Briefly two large vicryl stitches were passed using a large sized needle below and lateral to the lower edge of the uterine incision angle in anteroposterior direction and then redirected from back to the front through avascular window in the posterior leaf of the broad ligament just lateral to the uterine border taking care to avoid injury to bowel posteriorly or bladder/ureter anteriorly. The stitches were tied securely anteriorly

  • modified O, lreay suture

    Procedure/Surgery

    1. Pack Douglas- pouch with a towel. 2. Straight the used vicryl needle mostly no 1. 3. Try to compress and approximate anterior and posterior uterine walls. 4. Start from anterior to posterior 3- 4 cm medial to lateral uterine margin and then pass from posterior to anterior through avascular area in the broad ligament. And we repeat the procedure on the other side. We can repeat this method of uterine ligation at another different plane if needed.

Treatment groups

172 Participants
are divided into 2 treatment groups
Group A: O- lreay technique groupOther 1 intervention
Group B: Modified O- lreay technique groupOther 1 intervention

Trial outcomes

Primary outcomes

1

Amount of blood loss

The primary outcome for the study is the total volume of blood loss in the intra and postoperative period.

Time frame
6 hours postoperatively

Secondary outcomes

1

Maternal morbidity

Coagulopathy, need for massive blood transfusion (\> 4 units), length of hospital stay, and visceral injuries ICU admission and post-operative pain.

Time frame
24 hours post operatively
2

Maternal mortality

Maternal death

Time frame
24 hours postoperatively

Other outcomes

1

Gynecological conditions

Gynecological complications as amenorrhea, intrauterine adhesions and niche formation.

Time frame
6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nesreen Abdel Fattah Abdullah Shehata

Lead sponsor

Beni-Suef University

Sponsor institution

Source ClinicalTrials.gov
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