Amniotomy for Second-trimester Pregnancy Termination

Not Applicable

Completed

• Conditions: Abortion, Missed
• Interventions: Device: Foley catheter balloon; Procedure: Amniotomy; Drug: Oxytocin

• Registration Number: NCT04906278
• Lead Sponsor: Assiut University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-25
• Study First Submitted QC: 2021-05-25
• Study First Posted: 2021-05-28
• Study Start: 2021-11-01
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-28
• Last Update Posted: 2023-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amniotomy group	Foley catheter balloon	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.
Amniotomy group	Oxytocin	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.
No-amniotomy group	Foley catheter balloon	No-amniotomy will be done
Amniotomy group	Amniotomy	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.
No-amniotomy group	Oxytocin	No-amniotomy will be done

Primary Outcome Measures

Name	Time	Method
The interval between induction to complete abortion	15 hours

Trial Locations

Locations (1)

Woman's Health Hospital - Assiut university; 🇪🇬 Assiut, Egypt