An interventional study of Foley catheter balloon and Amniotomy in Abortion, Missed, sponsored by Assiut University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2023-08-29.
Sponsored by Assiut University · Not applicable, Interventional, and Treatment
The termination of abortion is an important issue that has many controversies. The most common time of serious abortion-related complications is the second trimester. Missed abortion is one of the most common indications of termination of pregnancy in the second trimester. Misoprostol and mifepristone are effective drugs for induction of abortion but these drugs are now expensive, and non-available in many developing countries.
The effectiveness of Foley's catheter balloon on cervical ripping for mid-trimester pregnancy termination has been proved before. It can effectually shorten the time of the expulsion of the fetus. Amniotomy defines as an artificial rupture of the membranes; it is an ordinary obstetric practice used mainly in the induction of labor, with good results and less morbidity. The obstetricians used to combine amniotomy with other methods such as prostaglandins or oxytocin to induce labor in a woman with an unfavorable cervix.
Despite plenty of studies that investigated the role of amniotomy for induction of labor but the studies which addressed the role of amniotomy in the induction of second-trimester abortion are very scarce in the literature.
53 studies on the registry are indexed under Abortion, Missed; 10 are open to participants now.
This study's enrollment of 60 is below the median of 142 across 44 interventional studies indexed under Abortion, Missed.
Browse Abortion, Missed studies →Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Amniotomy will be performed by toothed forceps. The handle of the device will be held with one hand outside the vagina while 2 fingers of the opposite hand will be placed in the vagina to guide the tip.
Device: Foley catheter balloon · Procedure: Amniotomy · Drug: Oxytocin
No-amniotomy will be done
Device: Foley catheter balloon · Drug: Oxytocin
A Cusco speculum will be placed and a 16F Foley catheter will be inserted into the cervix using ring forceps. Then the balloon will be inflated with 40 ml of saline and it will be pulled out to ensure the balloon covered the internal os of the cervix
Amniotomy will be performed by toothed forceps. The handle of the device will be held with one hand outside the vagina while 2 fingers of the opposite hand will be placed in the vagina to guide the tip. Care should be taken to protect maternal vaginal tissues from the forceps. Once the forceps reach the amniotic sac, the tip is pushed up against the sac with the index or middle finger of the internal hand to pierce the membranes. The nature of amniotic fluid will be checked.
The intravenous oxytocin infusion will be administered as 10 IU oxytocin/ 500 ml glucose/ 30 mIU/minute were every 6 hours till complete abortion occurs.
The interval between induction to complete abortion
Time frame: 15 hours
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Assiut University