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New treatment option for Genital Diseases, Female
Official title Randomized Study of a Dematerialized Management for Post-Emergency Gynecological Follow-Up
ClinicalTrials.gov ID: NCT06615843
What this study is testing
- What it's testing
- The GYNAB study aims to compare patient satisfaction and clinical outcomes between dematerialized post-emergency gynecological follow-up using a connected health app and traditional in-person follow-up. Conducted by Drs.
- Time commitment: about 24 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60, women only
You may be able to join if
- Women aged 18 and 60 years
- No consultation at the gynecological emergency department in the previous month and/or for the same pregnancy.
- Requires post-emergency follow-up for one of the following clinical conditions:
- Genital Infections (IGH): Acute pelvic pain with or without leucorrhea requiring antibiotic treatment
- Ectopic Pregnancy (GEU): Non-complicated, not ruptured, no significant effusion on ultrasound, GEU \< 4 cm, no cardiac activity if embryo present...
You likely can't join if
- Severe clinical intolerance, defined by:
- Signs of severe sepsis with unstable hemodynamics (TA with SBP \< 90 mmHg and FC ≥ 105 bpm)
- Abdominal defense or contracture
- Pain not controlled by level 1 analgesics (EVA \<7)
- Severe dehydration defined by a body weight loss of more than 10%
- Total food intolerance due to vomiting necessitating hospitalization
See the full eligibility criteria
- Women aged 18 and 60 years
- No consultation at the gynecological emergency department in the previous month and/or for the same pregnancy.
- Requires post-emergency follow-up for one of the following clinical conditions:
- Genital Infections (IGH): Acute pelvic pain with or without leucorrhea requiring antibiotic treatment
- Ectopic Pregnancy (GEU): Non-complicated, not ruptured, no significant effusion on ultrasound, GEU \< 4 cm, no cardiac activity if embryo present, stable hemodynamic state, HCG \< 5000, compliant patient, no...
- Early Pregnancy of Uncertain Viability (GLI): Early stage with a positive bHCG test, no visible gestational sac on ultrasound, no effusion, bHCG \< 1500 IU
- Missed Miscarriage (GAM): Confirmed by an intrauterine gestational sac ≥ 25mm without an embryo or an intrauterine gestational sac with an embryo ≥ 7mm without visible cardiac activity, treated with Misoprostol
- First Trimester Bleeding (MTRt1): Moderate vaginal bleeding with an ongoing intrauterine pregnancy without hemodynamic instability
- Hyperemesis Gravidarum (VG): Severe vomiting before 12 weeks of pregnancy without severe criteria necessitating emergency follow-up
- Severe clinical intolerance, defined by:
- Signs of severe sepsis with unstable hemodynamics (TA with SBP \< 90 mmHg and FC ≥ 105 bpm)
- Abdominal defense or contracture
- Pain not controlled by level 1 analgesics (EVA \<7)
- Severe dehydration defined by a body weight loss of more than 10%
- Total food intolerance due to vomiting necessitating hospitalization
- Uncontrolled active hemorrhage
- Significant ultrasound findings:
- Tubo-ovarian abscess ≥ 3 cm
- Significant intra-abdominal effusion
- Non-French speaking patients
- Inability to download or use the digital application due to precarious or isolated digital circumstances
- Refusal to sign consent form
- Patients under legal guardianship or court protection (tutelage, curatorship, or guardianship)
- Patients not affiliated with a social security system
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.