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Completed

NCT Number: NCT04981483

Conservative Surgery for Placenta Accreta

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

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ain SHams Maternity Hospital

Cairo, Abbaseya, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

conservative surgery for uterus in placenta accreta

Procedure

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

Primary outcomes

  1. incidence rate of conserving woman's uterus

    Time frame: intraoperative

    success rate of conservative surgery for placenta accreta

Secondary outcomes

  1. number of units of packed red blood cells , Fresh Frozen Plasma transfused ,postoperative haemoglobin

    Time frame: till 48 hours postpartum

    to assess blood loss

  2. incidence rate of cesarean hysterectomy needed

    Time frame: intraoperative and 48 hours postpartum

    failure of conservation , increase in blood loss

  3. incidence of puerperal sepsis

    Time frame: till 6 weeks postpartum

    temperature chart every 6 hours in 1st 48 hours postpartum then follow up visits 2 weeks and 6 weeks postpartum

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 29, 2021
Registry last updated
Dec 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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