Clinical trials: Vaginal Delivery
Pelvic Floor, Perineal Rupture
Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions Before the Delivery
The mechanical demands placed on the pelvic floor structures during vaginal delivery often exceed physiological tissue limits, resulting in maternal childbirth trauma, considerable postpartum morbidity, and increased risk of…
- Conditions
- Pelvic Floor, Perineal Rupture, Obstetric Trauma
- Trial name
- NCT03883867
- Where
- 3 sites in United States, Czechia
- Volunteers
- 20 people
- Sponsor
- Advanced Tactile Imaging, Inc.
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
HIV Infections
Feasibility Study of a Vaginal Ring for Delivery of TMC120 (Dapivirine)
The purpose of this trial was to evaluate the safety and feasibility of using a vaginal ring to deliver the candidate microbicide TMC120 (dapivirine).
- Trial name
- NCT00700284
- Testing
- TMC120 (dapivirine) vaginal ring
- Where
- Belgium
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
Induction of Labour
REgistry of MisOprostol 200 µg Vaginal dElivery System
The design of the study is post-marketing, observational, multi-centre and open-label. The study does not provide treatment; only patients to whom misoprostol 200 µg vaginal delivery system (VDS) is prescribed may be included.
- Trial name
- REMOVE (NCT02242214)
- Testing
- Misoprostol
- Where
- Netherlands
- Volunteers
- 106 people
- Sponsor
- Ferring Pharmaceuticals
Post-Partum Hemorrhage
Fibrinogen in Haemorrhage of Delivery
The purpose of the study is to assess the benefits of a therapeutic strategy that associates an early administration of human fibrinogen concentrate in the management of PPH on the reduction of bleeding after the initiation of…
- Trial name
- FIDEL (NCT02155725)
- Testing
- Human Fibrinogen concentrate
- Where
- 31 sites in France, Martinique
- Volunteers
- 448 people
- Sponsor
- Laboratoire français de Fractionnement et de Biotechnologies
Hemorrhoids
Prevention and/or Reduction of Hemorrhoids and/or Thrombosed External Hemorrhoids Using the HEM-AVERT Perianal Stabilizer Instrument
This study is being conducted to evaluate an investigational instrument called the HEM-AVERT Perianal Stabilizer and its efficacy in reducing the occurrence or severity of hemorrhoids and thrombosed external hemorrhoids (TEH)…
- Trial name
- HEM-AVERT (NCT00487045)
- Testing
- Hem-Avert Perianal Stabilizer
- Where
- 3 sites in United States
- Volunteers
- 176 people
- Sponsor
- Stetrix, Inc.
Obstetric Anal Sphincter Injury, Delivery Complication
Impedance Spectroscopy for Obstetric Anal Sphincter Injuries Detection
The main purpose of the study is to evaluate the effectiveness and safety of the impedance spectroscopy device prototype in the detection of anal sphincter injuries in women in the early postpartum period.
- Conditions
- Obstetric Anal Sphincter Injury, Delivery Complication, Obstetric Complication
- Trial name
- NCT04181840
- Testing
- Blood and faeces tests, Impedance spectroscopy test, Full gynecological and proctological examination
- Where
- Poland
- Volunteers
- 49 people
- Sponsor
- OASIS Diagnostics S.A.
Vaginal Dysbiosis
Effect of FB301 on Vaginal Bacterial Profile in Women With Asymptomatic Vaginal Dysbiosis Undergoing a Mock Frozen Embryo Transfer Cycle
The goal of this clinical trial is to evaluate FB301 during a mock frozen embryo transfer (FET) cycle in pre-menopausal women aged 18 to 45 years with a prior failed FET and a defined vaginal bacterial imbalance (dysbiosis).
- Trial name
- NCT07453069
- Testing
- FB-301, Chlorhexidine (0.5%) Vaginal Cleanse
- Where
- 4 sites in United States
- Volunteers
- 30 people
- Sponsor
- Freya Biosciences ApS
Infertility
Subcutaneous Progesterone in Frozen- Thawed Single Euploid Blastocyst Transfer.
This is a multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority clinical study in women aged 35 to 42 years.
- Trial name
- PROGRESS (NCT04549116)
- Testing
- Progesterone-IBSA Injectable Solution, Progesterone Vaginal Gel with Applicator
- Where
- 24 sites in United States
- Volunteers
- 688 people
- Sponsor
- IBSA Institut Biochimique SA
HIV Infections
A Pharmacokinetic Study of Dapivirine Vaginal Rings in Belgium
IPM 018 is a double-blind, randomized, placebo-controlled study conducted at one site in Belgium among 24 healthy, HIV-negative women to evaluate dapivirine release for 28 days from matrix and reservoir intravaginal rings, each…
- Trial name
- NCT00469768
- Testing
- dapivirine reservoir intravaginal ring, dapivirine matrix intravaginal ring
- Where
- Belgium
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
Episiotomy Wound
Novosyn® Quick in Patients Undergoing Episiotomy Closure
Retrospective, monocentric clinical study on the clinical performance of Novosyn® Quick in patients undergoing episiotomy closure.
- Trial name
- RETRO-EPINOQ (NCT05233527)
- Testing
- Episiotomy Closure
- Where
- Spain
- Volunteers
- 229 people
- Sponsor
- Aesculap AG
Infertility
Prolutex in Frozen Embryo Transfer Cycles At the Blastocyst Stage (PROGEX)
The objective of this proof of concept clinical trial is to evaluate the impact of two different progesterone treatments for endometrial preparation (25 mg/twice-a-day, subcutaneous injection, and 200 mg/three times a day…
- Trial name
- PROGEX (NCT03701490)
- Testing
- Progesterone subcutaneous, Progesterone Vaginal Product
- Where
- 3 sites in Spain
- Volunteers
- 213 people
- Sponsor
- IBSA Institut Biochimique SA
Vaginal Laxity Following Childbirth, Sexual Function Following Childbirth
VIveve Treatment of the Vaginal Introitus to EValuate Effectiveness
Outside United States (OUS) Post-Market Parallel Group Exploratory Study Design The objective of this study is to determine the safety and effectiveness of the Viveve System to treat the vaginal introitus in women following…
- Trial name
- VIVEVE I (NCT02261974)
- Testing
- Active Treatment Viveve
- Where
- 9 sites in Canada, Italy and 2 more
- Volunteers
- 186 people
- Sponsor
- Viveve Inc.
Premature Birth
Vaginal Progesterone in Twins With Short Cervix
A Multicenter, Double-Blind, Placebo-Controlled Randomized Clinical Trial of Vaginal Progesterone to Prevent Early Preterm Birth In Twin Pregnancy with Short Cervix.
- Trial name
- NCT01812239
- Testing
- Vaginal Progesterone gel., fetal fibronectin swab.
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Obstetrix Medical Group
Pre Term Birth
Comparing the Pharmacokinetics of a Progesterone Ring Versus a Progesterone Vaginal Insert
This study is looking for healthy female adults to use an vaginal ring with differing amounts of the hormone progesterone and go through a series of blood draws to measure how much progesterone is in the body following the use of…
- Trial name
- NCT06668896
- Testing
- Progesterone
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Daré Bioscience, Inc.
HIV Infections
A Safety Study to Assess the Delivery of Dapivirine From a Matrix Vaginal Ring
The proposed study is a single-center, double-blind, randomised, placebo-controlled trial to evaluate the delivery of dapivirine from matrix vaginal rings over a 56 and 57 day period and to assess the safety as compared to…
- Trial name
- NCT01144676
- Testing
- dapivirine
- Where
- Belgium
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
Pharmacokinetics
Expanded Use PK of Dapivirine Vaginal Ring
Study will evaluate the vaginal and blood pharmacokinetics of dapivirine from a vaginal ring containing 25 mg worn for 1, 2, 4, 8 or 12 months.
- Trial name
- NCT01952561
- Testing
- dapivirine ring
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
Luteal Hormone Supplementation in In-vitro Fertilization, Embryo Transfer
Phase 3 Trial to Evaluate the Efficacy and Safety of COL-1620 Vaginal Progesterone Gel
The primary objective of this trial is to demonstrate the non-inferiority of the clinical pregnancy rate per embryo transfer to the historical standard value in in-vitro fertilization (IVF)/embryo transfer (ET) cycles in Japan…
- Trial name
- NCT01863680
- Testing
- COL-1620, Gonadotropin-releasing hormone (GnRH) analogue, Follicle-stimulating hormone (FSH)
- Where
- 5 sites in Japan
- Volunteers
- 178 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Pharmacokinetics, Hormone Deficiency
Pharmacokinetics of a Novel Vaginal Delivery System for Testosterone and Dehydroepiandrosterone (DHEA)
This study was performed to determine the pharmacokinetic parameters of vaginal rings that contain DHEA, testosterone, or combinations of both androgens, in comparison to the oral administration of DHEA and the transdermal…
- Trial name
- NCT03967964
- Testing
- Dehydroepiandrosterone 2.2 g, Dehydroepiandrosterone 1.5 g/Testosterone 25 mg, Testosterone
- Where
- Chile
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Laboratorios Andromaco S.A.
Preterm Delivery, Short Cervix
PREGNANT Short Cervix Trial
The purpose of this research study is to evaluate the usefulness of progesterone vaginal gel in decreasing the preterm birth rate in a population of pregnant women with short cervical length and at high risk for preterm birth.
- Conditions
- Preterm Delivery, Short Cervix, Short Uterine Cervical Length
- Trial name
- NCT00615550
- Testing
- progesterone
- Where
- 49 sites in United States, Belarus and 8 more
- Volunteers
- 465 people, healthy volunteers welcome
- Sponsor
- Juniper Pharmaceuticals, Inc.