Amniotomy for Second-trimester Pregnancy Termination

Study Overview
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Brief Summary
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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.

Official Title
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Sequential Use of Foley Catheter With Amniotomy for Second-trimester Pregnancy Termination

Conditions
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Abortion, Missed

Intervention / Treatment
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* Device: Foley catheter balloon
* Procedure: Amniotomy
* Drug: Oxytocin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged 18-40 years old. Women who are pregnant in singleton mid-trimester missed abortion (18-26 weeks). Bishop's score is ≤ 4. Exclusion Criteria: Women who delivered before by classic caesarian section or had a history of -myomectomy, hysteroscopic uterine surgery, or cervical surgery like conization. Women with multiple gestations. Women with ultrasonography evidence of low amniotic fluid volume. Women with rupture of fetal membranes. Women with evidence of low implanted placenta by ultrasound. History or laboratory evidence of intra-uterine infection. History is suggestive of latex allergy. Women with severe anemia, hypertension, diabetes, or with coagulopathy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Amniotomy group<br>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<br>* 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<br>Procedure: Amniotomy<br>* 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.<br>Drug: Oxytocin<br>* 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.<br>|
| Other: No-amniotomy group<br>No-amniotomy will be done | Device: Foley catheter balloon<br>* 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<br>Drug: Oxytocin<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The interval between induction to complete abortion |  | 15 hours |