Clinical trials: Vaginal Delivery
Pregnancy, Childbirth
Comparison of the Flexibility of the Perineum in Primiparous Women Using the Medical Device Emagina During 90 Days of Their Pregnancy Compared to Those Having a Standard Pregnancy Follow-up
The goal of this clinical investigation is to learn if training with Emagina device can improve flexibility of the perineum during childbirth with the help of a balloon that inflates in the genital area according to a…
- Trial name
- PeriFlex (NCT06542744)
- Testing
- Training with the Emagina device at home until birth, No intervention
- Where
- 15 sites in France
- Volunteers
- 88 people
- Sponsor
- Mumming
Childbirth
A Clinical Phase II Study of the Materna Device to Shorten Delivery Time During Childbirth
This feasibility study is a prospective, non-randomized, single arm study to evaluate safety and prevention of maternal pelvic soft-tissue damage using the Materna Medical Device.
- Trial name
- NCT06698185
- Testing
- Materna Prep Device
- Where
- United States
- Sponsor
- Materna Medical
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
Contraceptive Usage
Efficacy, Safety, and Tolerability of Levonorgestrel Vaginal System
The goal of this clinical trial is to learn if drug levonorgestrel vaginal ring works as a contraceptive adult and adolescent females who are able to conceive (i.e. get pregnant).
- Trial name
- NCT07734155
- Testing
- Levonorgestrel
- Volunteers
- 1,600 people
- Sponsor
- Chemo Research
Luteal Hormone Supplementation
A Phase III Study of FE 999913 in Japanese Female Patients Undergoing Fertility Treatment
The purposes of the study are to verify sufficient supplementation of luteal hormone after administrating FE999913 Vaginal Tablet twice a day (BID) or three times a day (TID) and to determine the efficacy and safety of FE999913…
- Trial name
- NCT01710514
- Testing
- FE 999913 vaginal tablet
- Where
- 6 sites in Japan
- Volunteers
- 108 people
- Sponsor
- Ferring Pharmaceuticals
Intra-Amniotic Infection of Foetus
Rapid Amniotic Fluid (AF) Test and a Non-Invasive Vaginal Fluid (VF) Test
A multi-centered, prospective study, involving pregnant women presenting to the labor and delivery unit of collaborating clinical study sites with preterm labor and intact amniotic membranes with and without suspected…
- Trial name
- NCT03497234
- Testing
- Perilynx Analyzer to measure AF and VF fluid
- Where
- 5 sites in United States
- Sponsor
- Hologic, Inc.
Microbial Colonization
Investigating the Impact of Humiome B2 (Colon Delivered Riboflavin) and Riboflavin-overproducer Probiotic Strain Limosilactobacillus Reuteri AMBV339 on Intestinal and Vaginal Microbiome and Health of Healthy Adult Women (The VIAB2L Project)
The goal of this clinical trial is to learn if the probiotic strain Limosilactobacillus reuteri AMBV339 or colon-delivered riboflavin or their combination can change the gut and vaginal microbiome and metabolomics.
- Trial name
- VIAB2L (NCT06425081)
- Testing
- Limosilactobacillus reuteri AMBV339, Humiome B2, Limosilactobacillus reuteri AMBV339 + Humiome B2
- Where
- Belgium
- Volunteers
- 185 people, healthy volunteers welcome
- Sponsor
- dsm-firmenich Switzerland AG
Female Sexual Dysfunction
Viveve Geneveve Treatment of the Vaginal Introitus to Evaluate Safety and Efficacy
This study is evaluating the safety and efficacy of the Geneveve Treatment for women experiencing diminished sexual function following vaginal childbirth.
- Trial name
- VIVEVE II (NCT03479229)
- Testing
- Geneveve Treatment
- Where
- 21 sites in United States, Canada
- Volunteers
- 250 people
- Sponsor
- Viveve Inc.
Post Partum Hemorrhage
Sublingual Oxytocin for the Prevention of Post-partum Hemorrhage
An open-label, randomized, single-center, dose ascending trial will be conducted to evaluate the efficacy and safety of sublingual oxytocin for the prevention of post-partum hemorrhage caused by uterine atony in term pregnant…
- Trial name
- NCT06968481
- Testing
- Oxytocin sublingual, Oxytocin IM
- Where
- Nigeria
- Volunteers
- 330 people
- Sponsor
- Insud Pharma
Stress Urinary Incontinence, Intrinsic Sphincter Deficiency
Post Market Clinical Study to Evaluate a Mid-Urethral Vaginal Tape Procedure With a Pre-Pubic Delivery Approach, for the Treatment of Stress Urinary Incontinence
The pre-pubic approach of the tension free vaginal sling placement is a new approach in the treatment of SUI. The retropubic approach of the tension free vaginal sling is the standard method of device delivery; in addition a…
- Trial name
- NCT00688298
- Testing
- Prefyx PPS™ System, Advantage ™ System
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Boston Scientific Corporation
Vaginal Delivery, Pelvic Organ Prolapse
EASE: The Materna Prep Pivotal Study
This study is designed to evaluate the safety and effectiveness of the Materna Prep Device in reducing pelvic muscle injuries during vaginal delivery.
- Trial name
- NCT03973281
- Testing
- Materna Prep Device, Standard of Care (SOC)
- Where
- 22 sites in United States
- Volunteers
- 420 people
- Sponsor
- Materna Medical
Focus is on Healthy Subjects
Vaginal Detection of Orally Delivered Probiotic Strains in Healthy Women
The purpose of the present study is to obtain more information on the transit of orally ingested probiotics to the vagina.
- Trial name
- VSS2 (NCT07246161)
- Testing
- Probiotic Formula 1, Probiotic Formula 2, Probiotic Formula 3
- Where
- Canada
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Lallemand Health Solutions
Pregnancy
Vaginal Progesterone to Reduce the Risk of Another Preterm Birth
This research study is being conducted at over 12 pregnancy research centers in the US. The study will compare an investigational treatment with a placebo (a treatment without medication).
- Trial name
- NCT00086177
- Testing
- 8% progesterone vaginal gel
- Where
- 45 sites in United States
- Volunteers
- 636 people, healthy volunteers welcome
- Sponsor
- Juniper Pharmaceuticals, Inc.
HIV Infections
Safety and Pharmacokinetic Trial in Healthy HIV-Negative Women to Assess the Delivery of Dapivirine From a Vaginal Ring
The proposed study is a single center, double-blind placebo-controlled trial to assess the safety and tolerability of the dapivirine ring as compared to a placebo ring when inserted for 28 days in 16 healthy, HIV-negative women.
- Trial name
- NCT02920827
- Testing
- Dapivirine Vaginal Ring
- Where
- Belgium
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
HIV
A Trial In Healthy HIV-Negative Women To Assess The Effect Of Menses And Tampon Use On The Pharmacokinetics Of Dapivirine, Delivered By Dapivirine Vaginal Ring-004, Containing 25 Mg Of Dapivirine
A Two-Cohort, Open-Label, Randomised, Three-Period Crossover Trial In Healthy HIV-Negative Women To Assess The Effect Of Menses And Tampon Use On The Pharmacokinetics Of Dapivirine, Delivered By Dapivirine Vaginal Ring-004…
- Trial name
- NCT02858024
- Testing
- Dapivirine Vaginal Ring-004 and no tampons, Dapivirine Vaginal Ring-004 with tampons, Dapivirine Vaginal Ring-004 with no menses
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
HIV Infections
A Safety and Acceptability Study of a Vaginal Ring Microbicide Delivery Method
The proposed study is a multi-centre, open-label crossover study to assess the safety and acceptability of a silicone elastomer vaginal ring (containing no drug) when inserted for a 12 week period in 200 healthy, sexually active…
- Trial name
- NCT00469170
- Testing
- intravaginal ring
- Where
- 4 sites in South Africa, Tanzania
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
Contraception, Birth Control
Safety of a Contraceptive Copper Vaginal Ring
Many birth control options today come with unwanted side effects or risks. Hormonal methods can affect both mental and physical health, while devices like copper IUDs carry risks such as uterine perforation or infection.
- Conditions
- Contraception, Birth Control, Pregnancy Prevention
- Trial name
- NCT07666997
- Testing
- Vaginal Ring
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Elle, MD Biotechnologies Inc.
Luteal Phase Insuffiency, Progesterone Delivery
First in Human Safety and Ease of Use Assessment of 400mg Progesterone Callavid in Women With Luteal Phase Insufficiency
The aim of this clinical trial is to assess safety of a new vaginal 400mg progesterone drug-device combination product in a first in human trial.
- Trial name
- FREEDOM (NCT07136922)
- Testing
- 400mg progesterone Callavid - 2hr wear, Cyclogest 400 mg, 400mg progesterone Callavid - 3hr wear
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- Calla Lily Clinical Care Ltd
Perineal Trauma
Ward-Level Implementation and Post-Market Clinical Follow-up Study of ASISU Under Routine Clinical Practice
This is a single-center, prospective, non-randomized post-market clinical follow-up study evaluating the implementation and clinical performance of ASISU during routine vaginal childbirth.
- Trial name
- ASISU-PMCF (NCT07844005)
- Testing
- Perineal protection device
- Where
- Denmark
- Volunteers
- 280 people, healthy volunteers welcome
- Sponsor
- oasicare ApS
Vaginal Delivery, Pelvic Organ Prolapse
Materna Prep Study Phase II
This study is designed to evaluate the safety and effectiveness of the Materna Prep Device in reducing pelvic muscle injuries during vaginal delivery.
- Trial name
- EASE (NCT06126328)
- Testing
- Materna Prep Device
- Where
- 15 sites in United States
- Volunteers
- 214 people
- Sponsor
- Materna Medical