Amniotomy for Second-trimester Pregnancy Termination

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

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.

Study Overview

• Status: Completed
• Conditions: Abortion, Missed
• Intervention / Treatment: Device: Foley catheter balloon; Procedure: Amniotomy; Drug: Oxytocin

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71111
    • Woman's Health Hospital - Assiut university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: May 25, 2021
• First Submitted That Met QC Criteria: May 25, 2021
• First Posted (Actual): May 28, 2021

Study Record Updates

• Last Update Posted (Actual): August 29, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Abortion, Spontaneous; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Abortion, Missed; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: AM-FO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No