Second Trimester Pregnancy Termination in Women With Previous Caesarean Sections

Vaginal Misoprostol Versus Combined Intracervical Foley's Catheter and Oxytocin Infusion for Second Trimester Pregnancy Termination in Women With Previous Caesarean Sections

it is a randomized controlled trial comparing the safety and efficacy of Vaginal Misoprostol versus combined Intracervical Foley's Catheter and Oxytocin Infusion for Second Trimester Pregnancy Termination. the patients will be sorted into 2 groups, Group I (Misoprostol group): seventy-nine patients and Group II (Combined group): seventy- nine patients. safety and efficacy of the procedure will be followed up and documented.

Study Overview

• Status: Unknown
• Conditions: Second Trimester Abortion
• Intervention / Treatment: Procedure: compare misoprostol with combined oxytocin and cervical foly catheter

Detailed Description

Design: prospective randomized controlled trial Sitting: department of Obstetrics and Gynecology Faculty of Medicine, Zagazig University, Zagazig, Egypt Sample size calculation: thoroughly reviewing the use of vaginal misoprostol and intracervical Foleys catheter alone or in combination for mid trimester pregnancy termination, Rezk et al 2014 showed that the percentage of complications "fever and diarrhea" in the first group (misoprostol) was 30 % versus complications in the second group (intra cervical Foleys group)" cervical laceration "was 13.3 %. Therefore, at confidence level 95% and power 80%, using Epi info 7 the Sample size will be one hundred fifty-eight (158) patients.

Study participants: the study will include women indicated for termination of pregnancy between 14weeks-23 weeks and 6 days of gestation. The investigators will involve patients with a singleton pregnancy with one or multiple cesarean delivery. The investigators will exclude all patients with critical co-morbidities: bleeding disorders, chorioamnionitis, low-lying placenta, rupture uterus, myomectomy and contraindication to misoprostol or latex allergy. All women will undergo history taking, general examination, and local assessment for the cervix. Departmental US to confirm the diagnosis and indication for termination and position of the placenta. Blood tests will be done including blood group, full blood count matching, Antibodies screening and viral markers.

Randomization: After meeting eligibility criteria all participants will be counseled to the clinical trial. A signed documented consent form will be attached to their medical records. The patients will be sorted into two groups using a computerized random number generator in a sequence of sealed, numbered opaque envelopes, with a 1:1randomization ratio.

Group I (Misoprostol group): seventy-nine patients will receive a loading dose of moistened misoprostol tablets (cytotec pfizer 400 mg) inserted vaginally and it will be followed by maintenance dose (200 mg) after six hours and repeated every 4 hours till the start of effective uterine contraction with maximum five doses in 24 hours duration .

Group II (Combined group): seventy- nine patients will get intracervical Foleys Catheter insertion .Exposure of the cervix by means of a sterile speculum, a 16F Foley catheter will be introduced into the cervical canal to induce cervical ripping. The catheter will be fixed through inflation of the balloon with 30 milliliters of sterile solution when the catheter will be beyond the internal cervical os. Slight traction of the catheter will be exerted through tapping it to the inner thigh. After six hours of Foleys catheter fixation, The investigators will start infusion of 10 IU of oxytocin on 500 ml ringer lactate by rate 125 ml\hr followed by one hour rest to allow diuresis. Increased gradually of oxytocin dose by 5IU each time until achieving regular uterine contraction, maximum five doses in twenty -four hours duration. Therefore the maximum dose of oxytocin 100 IU over 24 hrs duration to avoid water intoxication.

Failed induction of abortion is considered if no fetal expulsion occurred within twenty for hours from the use of primary method of termination. The Demographic data and serial clinical monitoring will be recorded by the assigned on duty registrar.

• Study Type: Interventional
• Enrollment (Anticipated): 158
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • East
    • Zagazig, East, Egypt, 44511
      • Recruiting
      • Zagazig University
      • Contact: tolba ewida street 2 zagazig, 2; Phone Number: 002/01004132040; Email: basem@zu.edu.eg
      • Contact: Email: basemhamedobgyne@yahoo.com.sg
  • Sharkia
    • Zagazig, Sharkia, Egypt, 44511
      • Recruiting
      • Tolba Ewida Street
      • Contact: basem hamed; Phone Number: 01004132040; Email: basem@zu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 42 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• women indicated for termination of pregnancy between 14weeks-23 weeks and 6 days of gestation
• singleton pregnancy
• one or multiple cesarean delivery.

Exclusion Criteria:

• bleeding disorders
• chorioamnionitis
• low-lying placenta
• history of rupture uterus
• history of myomectomy
• contraindication to misoprostol

latex allergy.

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
Active Comparator: Group I (Misoprostol group): seventy-nine patients will receive a loading dose of moistened misoprostol tablets ( Cytotec pfizer 400 mg) inserted vaginally and it will be followed by maintenance dose (200 mg) after six hours and repeated every 4 hours till the start of effective uterine contraction with maximum five doses in 24 hours duration .	Procedure: compare misoprostol with combined oxytocin and cervical foly catheter; we will compare using misoprostol alone in one group with oxytocin and cervical catheter in the other group
Active Comparator: Group II (Combined group): seventy- nine patients will get intracervical Foleys Catheter insertion .a 16F (french units) Foley catheter will be introduced into the cervical canal to induce cervical ripping. The catheter will be fixed through inflation of the balloon with 30 milliliters of sterile solution when the catheter will be beyond the internal cervical os. After six hours of Foleys catheter fixation, we will start infusion of 10 international units (IU) of oxytocin on 500 ml ringer lactate by rate 125 ml\hr followed by one hour rest to allow diuresis. Increased gradually of oxytocin dose by 5 IU each time until achieving regular uterine contraction, maximum five doses in twenty -four hours duration.	Procedure: compare misoprostol with combined oxytocin and cervical foly catheter; we will compare using misoprostol alone in one group with oxytocin and cervical catheter in the other group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time to cervical dilatation in hours	time between starting the medications and the real cervical dilatation	24 hours
induction abortion interval in hours	time between induction of abortion and expulsion of the products of conception	48 hours
need for surgical evacuation	some cases may be presented with retained products of conception with the need for surgical evacuation of the uterus	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sever hemorrhage	comparing the prevalence of severe hemorrhage by postoperative hemoglobin percent in both groups.	48 hours
patients satisfaction	by patient written questionnaire about patient discomfort.	72 hours
post-abortive infection	Number of participants with post-abortive infection is predicted by post-abortive C reactive protein (CRP) level	7 days
rupture uterus	comparing the incidence of rupture uterus (clinically by sever abdominal pain and loss of uterine contractions and presence of free fluid by ultrasound) in both groups	48 hours

Collaborators and Investigators

• Sponsor: Zagazig University

Publications and helpful links

General Publications

• Elasy AN, Ibrahem MA, Elhawy LL, Hamed BM. Vaginal misoprostol versus combined intracervical foley's catheter and oxytocin infusion for second trimester pregnancy termination in women with previous caesarean sections: a randomised control trial. J Obstet Gynaecol. 2022 Sep 23:1-8. doi: 10.1080/01443615.2022.2118572. [Epub ahead of print]

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2020
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): January 1, 2021

Study Registration Dates

• First Submitted: July 15, 2020
• First Submitted That Met QC Criteria: August 3, 2020
• First Posted (Actual): August 6, 2020

Study Record Updates

• Last Update Posted (Actual): August 6, 2020
• Last Update Submitted That Met QC Criteria: August 3, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: abortion
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Oxytocin; Misoprostol
• Other Study ID Numbers: 6276/14-7-2020

Drug and device information, study documents

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