Amniotomy for Second-trimester Pregnancy Termination
Primary Purpose
Abortion, Missed
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Foley catheter balloon
Amniotomy
Oxytocin
Sponsored by
About this trial
This is an interventional treatment trial for Abortion, Missed
Eligibility Criteria
Inclusion Criteria:
- Women aged 18-40 years old.
- Women who are pregnant in singleton mid-trimester missed abortion (14-24 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.
Sites / Locations
- Woman's Health Hospital - Assiut university
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Amniotomy group
No-amniotomy group
Arm Description
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 will be done
Outcomes
Primary Outcome Measures
The interval between induction to complete abortion
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04906278
Brief Title
Amniotomy for Second-trimester Pregnancy Termination
Official Title
Sequential Use of Foley Catheter With Amniotomy for Second-trimester Pregnancy Termination
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
June 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abortion, Missed
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Amniotomy group
Arm Type
Other
Arm Description
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.
Arm Title
No-amniotomy group
Arm Type
Other
Arm Description
No-amniotomy will be done
Intervention Type
Device
Intervention Name(s)
Foley catheter balloon
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Amniotomy
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Intervention Description
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.
Primary Outcome Measure Information:
Title
The interval between induction to complete abortion
Time Frame
15 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Woman's Health Hospital - Assiut university
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Amniotomy for Second-trimester Pregnancy Termination
We'll reach out to this number within 24 hrs