Efficacy Study of Random Placenta Margin Incision to Treat Complete Placenta Previa
Condition: Complete Placenta Previa
MeSH terms: Placenta Previa
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

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.
    

Intervention name(s): Random Placenta Margin Incision
Intervention type(s): Procedure
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Complete Placenta Previa; Random Placenta Margin Incision; Cesarean Section; Hemorrhage