Termination of Pregnancy in Previous Scarred Uterus: PGE1 Versus Cervical Folleys
Comparison of the Efficacy of PGE1 Versus Cervical Folleys in Termination of Pregnancy in Previous Scarred Uterus
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Among unintended 205 million pregnancies that occur each year worldwide, about 20% of them end in induced abortion. Majority of these abortions occur during the first trimester of pregnancy. The second trimester of pregnancy is subdivided into an early period between 13-20 weeks and a late period between 20-28 weeks. Advanced screening techniques have led to an increase in the detection of congenital malformations with subsequent gradual increase in second trimester termination of pregnancy which represents 10-15% of total abortions performed worldwide. Termination in the second trimester is more risky than during first trimester. So the pharmacologic management seems to be an appealing alternative to surgical evacuation.
There is a wide range of prostaglandin preparations available which can be used for cervical ripening or induction of labour. Misoprostol is a synthetic prostaglandin E1 analogue. It was first used in obstetrics to induce abortion in 1988. Now it is widely used for induction of labour, termination of pregnancy and management of postpartum haemorrhage but still its use in obstetrics is not approved by FDA. Mechanical dilatation of cervix to induce abortion or labour is also known since 1833. The Foleys catheter traction is the cheapest, safest and successful mechanical method of cervical dilatation according to various studies. The decision regarding the effectiveness of any of the above two modality in women with previous cesarean is still a debate
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 4
Contacten en locaties
Studie Locaties
-
-
Punjab Province
-
Faisalabad, Punjab Province, Pakistan, 60000
- Hilal-e-ahmar Hospital
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- All women presented for termination of pregnancy (as per-operational definition).
- Patients with age 20-45 years
Exclusion Criteria:
- Women having multiple gestation.
- Women having any complication of miscarriage like bleeding, chorioamnionitis, disseminated intravascular coagulopathy.
- Women having any complication in previous cesarean like endometritis, re opening and scar dehiscence.
- Patients with molar or ectopic pregnancy (assessed on ultrasonography).
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: PGE1
Group A will receive 200µg orally five doses six hours apart.
If the patient did not abort after the first course, the same regimen will be repeated 24 hours after the start of the first dose of misoprostol
|
Group A will receive 200µg orally five doses six hours apart.
If the patient did not abort after the first course, the same regimen will be repeated 24 hours after the start of the first dose of misoprostol
|
|
Actieve vergelijker: cervical folleys
Group B will receive cervical foleys.
Foley's catheter group will be put in lithotomy position in examination room, vulva vagina will be cleaned with pyodine and sterile Sim's speculum will be introduced in the vagina, holding anterior cervical lip with sponge holding forceps and with the help of another sponge holding forceps a Foleys catheter no 14 Fr will be passed in the cervix into the extra amniotic space and balloon will be inflated with 30ml saline.
A urine bag will be filled with 500ml saline will be attached to the catheter for traction.
As soon as the catheter will be expelled reassessment of the dilatation of the cervix will be done and if needed infusion oxytocin will be started
|
Group B will receive cervical foleys.
Foley's catheter group will be put in lithotomy position in examination room, vulva vagina will be cleaned with pyodine and sterile Sim's speculum will be introduced in the vagina, holding anterior cervical lip with sponge holding forceps and with the help of another sponge holding forceps a Foleys catheter no 14 Fr will be passed in the cervix into the extra amniotic space and balloon will be inflated with 30ml saline.
A urine bag will be filled with 500ml saline will be attached to the catheter for traction.
As soon as the catheter will be expelled reassessment of the dilatation of the cervix will be done and if needed infusion oxytocin will be started
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Percentage of efficacy
Tijdsspanne: 48 hours
|
It refers to the ability of PGE1 or cervical Foleys to achieve complete abortion within 48 hours during the second trimester of fetal demise
|
48 hours
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Atiqa Noreen, Hilal-e-Ahmar Hospital, Faisalabad
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Hilal-e-Ahmer Hospital
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .