A Phase 2 interventional study of Random Placenta Margin Incision in Complete Placenta Previa, sponsored by Maternal and Child Health Hospital of Foshan. Completed at 1 site in China. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-13.
Sponsored by Maternal and Child Health Hospital of Foshan · Phase 2, Interventional, and Prevention
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.
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.
93 studies on the registry are indexed under Placenta Previa; 20 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 53 interventional studies indexed under Placenta Previa.
Browse Placenta Previa studies →Maternal and Child Health Hospital of Foshan is the lead sponsor of 8 studies on the registry; none are open to participants now.
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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.
Postpartum Hemorrhage
Time frame: within the first 30 days after cesarean section
Number of blood products transfused
Time frame: within the first 30 days after cesarean section
Length of hospitalization
Time frame: 6 months after delivery
Plan to share: Undecided
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This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Maternal and Child Health Hospital of Foshan