Second Trimester Pregnancy Termination in Women With Previous Caesarean Sections
NCT ID: NCT04501809
Last Updated: 2020-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
158 participants
INTERVENTIONAL
2020-07-15
2021-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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 .
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
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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* singleton pregnancy
* one or multiple cesarean delivery.
Exclusion Criteria
* chorioamnionitis
* low-lying placenta
* history of rupture uterus
* history of myomectomy
* contraindication to misoprostol
latex allergy.
17 Years
42 Years
FEMALE
No
Sponsors
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Zagazig University
OTHER_GOV
Responsible Party
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basem mohamed hamed khalil
lecturer of obstetrics and gynecology/ MD ob/gyn / consultant of obstetrics and gynecology
Locations
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Zagazig University
Zagazig, East, Egypt
Tolba Ewida Street
Zagazig, Sharqia Province, Egypt
Countries
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Facility Contacts
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Role: backup
References
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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 Oct;42(7):2962-2969. doi: 10.1080/01443615.2022.2118572. Epub 2022 Sep 23.
Other Identifiers
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6276/14-7-2020
Identifier Type: -
Identifier Source: org_study_id
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