Conservative Surgery for Placenta Accreta

Placenta Accreta Clinical Trial

Official title:

Long-term Follow-up of the Cases Who Underwent Conservative Surgery for Placenta Previa Accreta

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04981483
• Other study ID #: 11784
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: December 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A stepwise surgical approach for conservative management of placenta previa accreta.

Description:

a stepwise surgical approach for conservative management of placenta previa accreta to preserve women's uterus and to evaluate the efficacy and safety of this approach in controlling postpartum hemorrhage including intrapartum hemorrhage associated with conservative management.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: June 30, 2019
• Est. primary completion date: April 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Any age.

• Any parity.

• Previous one or more cesarean delivery.

• Placenta previa accreta diagnosis confirmed by gray scale & color flow Doppler ultrasound in 3rd trimester. All participants had undergone abdominal ultrasound showing placenta previa anterior completely covering the internal os, with criteria suggestive of invasion by U/S

Exclusion Criteria:

• women with medical disorder

• women with bleeding tendency

Related Conditions & MeSH terms

• Placenta Accreta

Intervention

Procedure:
• conservative surgery for uterus in placenta accreta
After removal of the placenta, grasping the cervix from the both lips and one from each side of the cervical canal at the level of the internal os, each uterine angle and grasped the remaining lower uterine segment and Nelaton catheter was inserted inside the cervical canal to avoid closing the cervix with sutures of the uterine incision.Closing the uterine incision;taking suture at the lateral angle of the cervix and suturing it to the lower edge of the uterine angle, then another continuous suture was attached to the upper edge of the uterine incision angle[outside in-in out then out in-in out] and the same technique was repeated on the other side (cervico-isthmic sutures). controlling bleeding from the inner surface of the remaining lower uterine segment was done by 2-3 interrupted sutures between the lower uterine segment and the anterior cervical lip. closing of the uterine incision in continuous non-locking manner

Locations

Country	Name	City	State
Egypt	Ain SHams Maternity Hospital	Cairo	Abbaseya

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence rate of conserving woman's uterus	success rate of conservative surgery for placenta accreta	intraoperative
Secondary	number of units of packed red blood cells , Fresh Frozen Plasma transfused ,postoperative haemoglobin	to assess blood loss	till 48 hours postpartum
Secondary	incidence rate of cesarean hysterectomy needed	failure of conservation , increase in blood loss	intraoperative and 48 hours postpartum
Secondary	incidence of puerperal sepsis	temperature chart every 6 hours in 1st 48 hours postpartum then follow up visits 2 weeks and 6 weeks postpartum	till 6 weeks postpartum