The Acceptability and Feasibility of an Alternative to Routine Follow-up Visit After Medical Abortion in Vietnam
The Acceptability and Feasibility of an Alternative to a Routine Follow-up Visit After Medical Abortion in Vietnam
This trial will compare the efficacy and acceptability of post-medical abortion follow-up by assigning women to either 1) alternative follow-up via routine semi-quantitative pregnancy test and a self-administered follow-up questionnaire, or 2) the standard of care: a routine follow-up visit including a bimanual exam and vaginal ultrasound.
The goal of the study is to provide answers to the following questions:
- Is a follow-up protocol that employs a self-administered questionnaire and at home use of a semi-quantitative pregnancy test effective at identifying women with ongoing pregnancies?
- Is an innovative follow-up protocol more acceptable to women and providers than the current standard of care?
- Is an innovative follow-up protocol feasible to implement in abortion services in Vietnam?
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
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Hanoi, Viêt Nam
- National Ob-Gyn Hospital
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Hanoi, Viêt Nam
- Hanoi Ob-Gyn Hospital
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Ho Chi Minh City, Viêt Nam
- HocMon District Hospital
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Ho Chi Minh City, Viêt Nam
- Hung Vuong Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Reproductive age women seeking medical abortion services
- Intrauterine pregnancy less than or equal to 63 days gestation on the day of mifepristone administration
- Hold a working, personal phone number
- be willing and able to sign consent forms and agree to comply with study procedures
Exclusion Criteria:
- Pregnancy greater than 63 days gestation on the day of mifepristone administration
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Aucune intervention: Standard of care for post medical abortion follow-up
Standard of care includes a routine hospital visit two weeks after mifepristone administration.
At the hospital visit, the woman will undergo a bimanual and vaginal ultrasound examination.
In the event the woman fails to return for the follow-up visit, each hospital will follow their standard procedure for contacting women who fail to attend their follow-up visit, i.e. three efforts to contact the woman.
Form 2a will document the results of any clinical examinations, any additional medical abortion-related care given and the abortion outcome.
At the follow-up visit, women will also be asked about the acceptability of current medical abortion follow-up procedures and their future preferences.
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Comparateur actif: Alternative follow-up
At their first clinic visit, women will be asked to provide their phone number for contact purposes. Women will also be asked to complete a semi-quantitative pregnancy test in the clinic and the results of the test will be noted on a study form. After mifepristone administration, women will be provided with a second semi-quantitative pregnancy test and a self-administered checklist. Women will be instructed to complete the checklist and perform the pregnancy test at home on an assigned date two weeks after mifepristone administration. The checklist will indicate that if the woman answers "yes" to any of the questions, then she should return to the clinic for a follow-up visit. On the assigned date, women will also be contacted by phone by the clinic staff. Women will be asked to confirm whether they completed the pregnancy test and checklist and asked to report on the results of both tests. |
After mifepristone administration, women will be provided with a second semi-quantitative pregnancy test and a self-administered checklist.
Women will be instructed to complete the checklist and perform the pregnancy test at home on an assigned data two weeks after mifepristone administration.
On the assigned date, women will also be contacted by phone by the clinic staff.
Women will be asked to confirm whether they completed the pregnancy test and checklist and asked to report on the results of both tests.
Provider will review the women's responses to the checklist and confirm whether, based on the woman's responses, she should return for a follow up visit.
During the follow-up phone call, women will also be asked about the satisfaction and acceptability of the alternative follow-up procedure.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Continued, ongoing pregnancy
Délai: 9 months
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9 months
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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percentage of women who return for follow-up
Délai: 9 months
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9 months
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percentage of women receiving other treatment for ongoing pregnancy
Délai: 9 months
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9 months
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Nguyen Thi Nhu Ngoc, MD, MSc, Center for Research and Consultancy in Reproductive Health
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 6.4
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