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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 4
Kontakte und Standorte
Studienorte
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Punjab Province
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Faisalabad, Punjab Province, Pakistan, 60000
- Hilal-e-ahmar Hospital
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Beschreibung
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).
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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
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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
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|
Aktiver Komparator: 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
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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
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Percentage of efficacy
Zeitfenster: 48 hours
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It refers to the ability of PGE1 or cervical Foleys to achieve complete abortion within 48 hours during the second trimester of fetal demise
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48 hours
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Atiqa Noreen, Hilal-e-Ahmar Hospital, Faisalabad
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- Hilal-e-Ahmer Hospital
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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