Clinical trials: Cervical Ripening
Cervical Ripening
A Randomised Trial Investigating the Efficacy and Safety of a Vaginal Insert in Pregnant Women at Term
To demonstrate the efficacy of dinoprostone vaginal insert (DVI) for cervical ripening success (either bishop score (BS) ≥7 or vaginal delivery) within 12 hours of vaginal insert administration
- Trial name
- NCT03067727
- Testing
- Dinoprostone
- Where
- 20 sites in Japan
- Volunteers
- 114 people
- Sponsor
- Ferring Pharmaceuticals
Cervical Ripening, Induction of Labor
Pharmacokinetic (PK) Study of the 200 Microgram (mcg) Misoprostol Vaginal Insert (MVI 200) in Women at Term Gestation (The MVI-PK Study)
The purpose of this study is to determine the pharmacokinetics (PK) of misoprostol acid for the MVI 200 in women requiring cervical ripening and induction of labor.
- Trial name
- NCT01283022
- Testing
- MVI 200
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Ferring Pharmaceuticals
Cervical Ripening, Induction of Labor
Misoprostol Vaginal Insert (MVI) 100, 150, 200 mcg for Cervical Ripening and Induction of Labor
The purpose of this study is to assess the efficacy and safety of the 100, 150 and 200 mcg Misoprostol Vaginal Insert (MVI 100, MVI 150 and MVI 200) for women requiring cervical ripening and induction of labor.
- Trial name
- NCT00828711
- Testing
- MVI 100, MVI 150, MVI 200
- Where
- 11 sites in United States
- Volunteers
- 374 people
- Sponsor
- Ferring Pharmaceuticals
Cervical Ripening, Pregnancy
General Drug Use-results Survey on PROPESS Vaginal Inserts in Treatment for Initiation of Cervical Ripening in Patients at Term (From 37 Completed Weeks of Gestation)
To confirm and consider the occurrence of important identified risks described in the Japanese Pharmaceutical Risk Management Plan (J-RMP) under conditions used in routine medical practice.
- Trial name
- NCT04773314
- Testing
- PROPESS Cohort
- Where
- Japan
- Volunteers
- 409 people
- Sponsor
- Ferring Pharmaceuticals
Labor, Induced
Recombinant Human Relaxin (rhRlx) in Pregnant Women Scheduled for Induction of Labor
The purpose of this study is to assess the safety and efficacy of rhRlx for cervical ripening, when compared to a placebo.
- Trial name
- NCT00259103
- Testing
- Serelaxin
- Where
- 3 sites in Russia
- Volunteers
- 72 people
- Sponsor
- Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
Labor Induction, Cervical Ripening
Safety and Efficacy Study of Misoprostol Vaginal Insert for Induction of Labour
The primary objective of the study was assessment of the efficacy of four dose reservoirs (25 mcg, 50 mcg, 100 mcg, 200 mcg) of intravaginal controlled release misoprostol administered for up to 24 hours.
- Trial name
- NCT00346840
- Testing
- Misoprostol vaginal insert 25 mcg, Misoprostol vaginal insert 50 mcg, Misoprostol vaginal insert 100 mcg
- Where
- 6 sites in United Kingdom
- Volunteers
- 124 people
- Sponsor
- Ferring Pharmaceuticals
Vaginal Delivery, Cesarean Section
Open Label Comparative Trial of Dinoprostone Plus or Minus Oxytocin Versus Oxytocin Alone in Cervical Ripening for Labor Induction
This is a comparative trial between oxytocin alone and dinoprostone for cervical ripening in unfavorable cervix pregnant women with 38 or more weeks of gestational age.
- Trial name
- SOFTNES (NCT01190163)
- Testing
- Dinoprostone, Oxytocin
- Where
- 4 sites in Brazil
- Volunteers
- 170 people
- Sponsor
- Ferring Pharmaceuticals
Cervical Ripening
An Open-label Trial Investigating the Efficacy and Safety of a Vaginal Insert in Pregnant Women at Term
To demonstrate the efficacy of controlled-release dinoprostone vaginal insert (DVI) for cervical ripening success (either Bishop Score (BS) ≥7 or vaginal delivery) within 12 hours of vaginal insert administration.
- Trial name
- NCT03067597
- Testing
- Dinoprostone
- Where
- 14 sites in Japan
- Volunteers
- 68 people
- Sponsor
- Ferring Pharmaceuticals
Cervical Ripening, Induction of Labor
Pharmacokinetics and Safety of the 100 Mcg Misoprostol Vaginal Insert (MVI 100)
This study will provide pharmacokinetic data for the MVI 100 (100 mcg) misoprostol vaginal insert when administered to nulliparous women at term gestation requiring cervical ripening and induction of labor.
- Trial name
- Miso-Obs-203 (NCT00528255)
- Testing
- Misoprostol Vaginal Insert (MVI 100)
- Where
- 6 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Ferring Pharmaceuticals
Labour Onset and Length Abnormalities, Labor; Forced or Induced, Affecting Fetus or Newborn
Dilapan-S/Dilasoft E-Registry in Induction of Labor
International Observational E-Registry on the use of DILAPAN-S® osmotic dilator / DILASOFT® osmotic dilator for cervical ripening prior to labour induction.
- Trial name
- DSREGISTRYIL (NCT02318173)
- Testing
- Dilapan-S
- Where
- 11 sites in United States, Czechia and 5 more
- Volunteers
- 444 people
- Sponsor
- Medicem International CR s.r.o.
Premature Rupture of Fetal Membranes
Evaluation of CRB in PROM Patients
The CRB study is designed to study the safety and effectiveness of the Cook Cervical Ripening Balloon (CRB) for the induction of labor in term and near-term patients with premature rupture of membranes (PROM).
- Trial name
- NCT01736852
- Testing
- CRB, Pitocin
- Where
- 4 sites in United States
- Volunteers
- 129 people
- Sponsor
- Cook Group Incorporated
Reducing Time to Vaginal Delivery, Cervical Ripening
Efficacy & Safety Study Comparing Misoprostol Vaginal Insert (MVI) Versus Dinoprostone Vaginal Insert (DVI) for Reducing Time to Vaginal Delivery
The purpose of this study is to determine whether the Misoprostol Vaginal Insert (MVI) 200 microgram (mcg) can decrease the time to vaginal delivery compared to the Dinoprostone Vaginal Insert (DVI) 10 milligram (mg) in pregnant…
- Conditions
- Reducing Time to Vaginal Delivery, Cervical Ripening, Induction of Labor
- Trial name
- EXPEDITE (NCT01127581)
- Testing
- MVI 200, Dinoprostone Vaginal Insert (DVI)
- Where
- 34 sites in United States
- Volunteers
- 1,358 people
- Sponsor
- Ferring Pharmaceuticals
Labor Onset and Length Abnormalities
Effect of Tafoxiparin on Cervical Ripening and Induction of Labor in Term Pregnant Women With an Unripe Cervix
The study is designed as a randomized, Double-Blind, Placebo-Controlled, Parallel-Group Proof of Concept Study (section A) with a conditional dose finding follow up (Section B) to Evaluate the Efficacy on Cervical ripening…
- Trial name
- NCT04000438
- Testing
- DF01, PL1
- Where
- 7 sites in Finland, Sweden
- Volunteers
- 365 people, healthy volunteers welcome
- Sponsor
- Dilafor AB
Cervical Ripening, Labor, Induced
Safety/Efficacy Study Comparing the Misoprostol Vaginal Insert to Cervidil for Cervical Ripening and Induction of Labor
The purpose of this study is to determine whether the misoprostol vaginal insert (50 mcg and 100 mcg) can safely and effectively speed time to vaginal delivery compared to Cervidil (R) in women who need to have cervical ripneing…
- Trial name
- NCT00308711
- Testing
- Misoprostol vaginal insert 100 mcg, Misoprostol vaginal insert 50 mcg, Dinoprostone vaginal insert (Cervidil)
- Where
- 52 sites in United States, Canada
- Volunteers
- 1,308 people
- Sponsor
- Ferring Pharmaceuticals
Post Date, Induction of Labor
Use of Single Versus Double Foley's Catheter in Pre-induction Cervical Ripening
Cervical ripening should be present before labor induction, which can generally be divided into two categories: pharmacological and mechanical
- Trial name
- NCT05511727
- Testing
- single versus double Foley's catheter in pre-induction cervical ripening
- Where
- Egypt
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Egymedicalpedia
Uterine Cervical Incompetence
Dilapan-S Osmotic Dilator in Pre-induction of Labor
Non-interventional prospective data collection designed to evaluate clinical outcome on the efficacy of the use of Dilapan-S in the indication of labor pre-induction in women with/without a history of Caesarean section.
- Trial name
- NCT02098382
- Testing
- Dilapan-S
- Where
- Czechia
- Volunteers
- 125 people
- Sponsor
- Medicem International CR s.r.o.