Efficacy Study of Random Placenta Margin Incision to Treat Complete Placenta Previa

Random Placenta Margin Incision for Hemorrhage Control During Cesarean Section of Complete Placenta Previa Pregnancies

The purpose of this study is to assess the efficacy of random placenta margin incision for hemorrhage control during cesarean section of complete placenta previa pregnancies.

Study Overview

• Status: Completed
• Conditions: Complete Placenta Previa
• Intervention / Treatment: Procedure: Random Placenta Margin Incision

Detailed Description

Placenta previa is used to describe a placenta that is implanted over or very near the internal cervical os and the complete placenta previa is defined that the internal os is covered completely by placenta. This obstetric complication is associated with high risks for maternal hemorrhage and emergency peripartum hysterectomy can be the only effective action to take, although it carries many morbidities for the women especially those with low parity. Although, nowadays the obstetrician can diagnose placenta previa before delivery, it is still one of the important causes of maternal mortality. The only safe and appropriate mode of delivery for placenta previa is by cesarean delivery. In the absence of accreta, this can usually be accomplished using a lower segment uterine incision. Because of cutting through the placenta, it is often associated with increased maternal bleeding. In addition, the umbilical cord will be also excessive blood loss when the placenta is transected. Theoretically, random placenta margin incision can effectively avoid the damage of the placenta and reduce the maternal blood loss.

The investigators conduct a prospective study to assess the efficacy of random placenta margin incision for hemorrhage control during cesarean section of complete placenta previa pregnancies at Department of Obstetrics, Southern Medical University Affiliated Maternal and Child Health Hospital of Foshan, since January 2016 till December 2016, after approval of the study protocol by the Local Ethical Committee.

All participants have complete placenta previa and provide written informed consent to undergo any procedure necessary as an attempt to avoid hysterectomy. And they also provide written informed consent to undergo hysterectomy if all measures attempted to preserve the uterus fail.

To precisely determine the placental location and the edge of the placenta, preoperative ultrasonography is used in determining the optimal place for the uterine incision. The investigator performed all cesarean deliveries and assisted by the second investigator. The parietal peritoneum is opened by sharp dissection and blunt expansion, if necessary, high above the bladder, a bladder flap is made and the bladder is retracted. A random hysterotomy incision is done in the placenta margin. It is expanded on both sides using scissors, stopping shortly before the uterine arteries. Active delivery of the placenta is attempted by searching manually for a plane of cleavage between the placenta and the uterus after delivery of the fetus. In addition to uterotonics, measures such as "oversewing" of the placental bed, intrauterine balloon tamponade, and B-Lynch or other compression sutures are also used depending on different circumstances.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Foshan, Guangdong, China, 528000
      • Maternal and Child Health Hospital of Foshan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• A gestation age of ≥ 28 weeks
• Delivered by cesarean section
• Antepartum diagnosis of complete placenta accreta by obstetric ultrasound and doppler

Exclusion Criteria:

• Women who refuse to participate
• Pregnant women with serious diseases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All Participants; A random hysterotomy incision is done in the placenta margin. To precisely determine the placental location and the edge of the placenta, preoperative ultrasonography is used in determining the optimal place for the uterine incision.	Procedure: Random Placenta Margin Incision; A random hysterotomy incision is done in the placenta margin. To precisely determine the placental location and the edge of the placenta, preoperative ultrasonography is used in determining the optimal place for the uterine incision.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Postpartum Hemorrhage	within the first 30 days after cesarean section

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of blood products transfused	within the first 30 days after cesarean section
Length of hospitalization	6 months after delivery

Collaborators and Investigators

• Sponsor: Maternal and Child Health Hospital of Foshan

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: February 22, 2016
• First Submitted That Met QC Criteria: February 25, 2016
• First Posted (Estimate): March 1, 2016

Study Record Updates

• Last Update Posted (Actual): November 13, 2017
• Last Update Submitted That Met QC Criteria: November 9, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Hemorrhage; Cesarean Section; Complete Placenta Previa; Random Placenta Margin Incision
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Placenta Diseases; Placenta Previa
• Other Study ID Numbers: MCHHFoshan-1601

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED