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The study is a Proof-of-concept study to evaluate if DF01 can prevent protracted labor. Time to delivery will be measured from the time of at least 3 cm cervix dilatation and 3 contractions of minimum one minute's duration/10 minutes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | DF01 |
|
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DF01 | Drug | Once daily s.c. injections from approximately 3-7 days before expected delivery (maximum 2 weeks before) until delivery (maximum 2 weeks after expected delivery) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time from the time of at least 3 cm cervix dilatation and 3 contractions of minimum one minute's duration/10 minutes until partus in women with vaginal delivery | See above |
| Measure | Description | Time Frame |
|---|---|---|
| Complications of labor | At delivery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lena Granstrom, MD | Kvinnokliniken Sodra Alvsborgs sjukhus Boras | Principal Investigator |
| Gunvor Ekman-Ordeberg, MD, PhD | Dilafor AB | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kvinnokliniken Alvsborgs sjukhus Boras | Borås | SE-501 82 | Sweden | |||
| Gavle sjukhus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38462256 | Derived | Ekman-Ordeberg G, Hellgren-Wangdahl M, Jeppson A, Rahkonen L, Blomberg M, Pettersson K, Bejlum C, Engberg M, Ludvigsen M, Uotila J, Tihtonen K, Hallberg G, Jonsson M. Tafoxiparin, a novel drug candidate for cervical ripening and labor augmentation: results from 2 randomized, placebo-controlled studies. Am J Obstet Gynecol. 2024 Mar;230(3S):S759-S768. doi: 10.1016/j.ajog.2022.10.013. Epub 2023 May 17. |
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| Placebo | Drug | Once daily s.c. injections from approximately 3-7 days before expected delivery (maximum 2 weeks before) until delivery (maximum 2 weeks after expected delivery) |
|
| Gävle |
| Sweden |
| Sahlgrenska/Ostra sjukhuset | Gothenburg | Sweden |
| Karolinska Universistetssjuhuset | Huddinge | Sweden |
| Lanssjukhuset Ryhov | Jönköping | Sweden |
| Lanssjukhuset | Kalmar | Sweden |
| Universitetssjukhuset | Linköping | Sweden |
| Universitetssjukhuset | Lund | Sweden |
| Vrinnevisjukhuset | Norrköping | Sweden |
| Nyköpings lasarett | Nyköping | Sweden |
| Universitetssjukhuset | Örebro | Sweden |
| Kärnsjukhuset | Skövde | Sweden |
| Danderyds sjukhus | Stockholm | Sweden |
| Sodersjukhuset | Stockholm | Sweden |
| Norra Älvsborgs länssjukhus | Trollhättan | Sweden |
| Akademiska sjukhuset | Uppsala | Sweden |
| Centrallasarettet | Vaxjo | Sweden |
| Centrallasarettet | Västerås | Sweden |