NCT06364098 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Awoleke JO, Adeyanju BT, Adeniyi A, Aduloju OP, Olofinbiyi BA
Randomised Controlled Trial of Sublingual and Rectal Misoprostol in the Prevention of Primary Postpartum Haemorrhage in a Resource-Limited Community. J Obstet Gynaecol India. 2020 Dec;70(6):462-470. doi: 10.1007/s13224-020-01338-0. Epub 2020 Jun 29.
Bagheri FZ, Azadehrah M, Shabankhani B, Nasiri Formi E, Akbari H
Rectal vs. sublingual misoprostol in cesarean section: Three-arm, randomized clinical trial. Caspian J Intern Med. 2022 Winter;13(1):84-89. doi: 10.22088/cjim.13.1.84.
Escobar MF, Nassar AH, Theron G, Barnea ER, Nicholson W, Ramasauskaite D, Lloyd I, Chandraharan E, Miller S, Burke T, Ossanan G, Andres Carvajal J, Ramos I, Hincapie MA, Loaiza S, Nasner D; FIGO Safe Motherhood and Newborn Health Committee
FIGO recommendations on the management of postpartum hemorrhage 2022. Int J Gynaecol Obstet. 2022 Mar;157 Suppl 1(Suppl 1):3-50. doi: 10.1002/ijgo.14116. No abstract available.
Gallos I, Williams H, Price M, Pickering K, Merriel A, Tobias A, Lissauer D, Gee H, Tuncalp O, Gyte G, Moorthy V, Roberts T, Deeks J, Hofmeyr J, Gulmezoglu M, Coomarasamy A
Uterotonic drugs to prevent postpartum haemorrhage: a network meta-analysis. Health Technol Assess. 2019 Feb;23(9):1-356. doi: 10.3310/hta23090.
Gallos ID, Williams HM, Price MJ, Merriel A, Gee H, Lissauer D, Moorthy V, Tobias A, Deeks JJ, Widmer M, Tuncalp O, Gulmezoglu AM, Hofmeyr GJ, Coomarasamy A
Uterotonic agents for preventing postpartum haemorrhage: a network meta-analysis. Cochrane Database Syst Rev. 2018 Apr 25;4(4):CD011689. doi: 10.1002/14651858.CD011689.pub2.

Comparative Study Between the Roles of Intrauterine Misoprostol Versus the Sublingual Route for Prevention of Postpartum Blood Loss in Elective Cesarean Sections: A Randomized Controlled Trial

Details for clinical trial NCT06364098

Clinical trial NCT06364098 - References