Misoprostol With or Without Letrozole in Treatment of Missed Miscarriage
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| ClinicalTrials.gov Identifier: NCT04593108 |
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Recruitment Status :
Active, not recruiting
First Posted : October 19, 2020
Last Update Posted : October 20, 2020
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Aim of study Compare the success rate of misoprostol with versus without letrozole as a pretreatment for medical termination of pregnancy during the first trimester.
Hypothesis:
Letrozole value as a pre-treatment medication for misoprostol in induction of abortion during the first trimester.
Research question:
Will letrozole- misoprostol protocol give better results than misoprostol- alone protocol in induction of abortion during the first trimester?
| Condition or disease | Intervention/treatment |
|---|---|
| Missed Abortion | Device: Letrozole misoprostol Drug: Misoprostol, placebo |
Aim of the Work
Compare the success rate of misoprostol with versus without letrozole as a pretreatment for medical termination of pregnancy during the first trimester.
Hypothesis:
Letrozole value as a pre-treatment medication for misoprostol in induction of abortion during the first trimester.
Research question:
Will letrozole- misoprostol protocol give better results than misoprostol- alone protocol in induction of abortion during the first trimester?
Primary outcome:
Complete abortion (complete expulsion of products of conception with no need for curettage) within one week from the first dose of misoprostol.
Secondary outcome:
• Curettage (surgical evacuation of the products of conception)
- Incomplete abortion (retained products of conception).
- Considerable bleeding that necessitates immediate evacuation.
| Study Type : | Observational |
| Estimated Enrollment : | 320 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Prospective |
| Official Title: | Study at Zagazig General Hospital |
| Actual Study Start Date : | January 15, 2019 |
| Actual Primary Completion Date : | October 1, 2020 |
| Estimated Study Completion Date : | November 15, 2020 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Letrozole misoprostol
Group (A): A participant will receive three tablets of letrozole (Letrozole®, Technopharma) as a single dose, each tablet 2.5 mg (total dose 7.5 mg per day) on day One, then she took the second dose herself on day Two and will be told to bring back the empty pack. The third dose will be given on admission to hospital on day Three followed by 4 tablets of vaginal misoprostol (200 μg) (Cytotec®, Pfizer) soaked with saline every three hours for maximum two doses.then give antibiotics when abortion start |
Device: Letrozole misoprostol
Letrozole give pretreatment of abortion by misoprostol |
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Misoprostol,placebo
Group (B): A participant will receive three tablets of placebo as a single dose on day One, then she took the second dose herself on day Two and will be told to bring back the empty pack. The third dose will be given on admission to hospital on day Three followed by 4 tablets of vaginal misoprostol (200 μg) (Cytotec®, Pfizer) soaked with saline every three hours for maximum two doses.then give antibiotics when abortion start |
Drug: Misoprostol, placebo
Give placebo pretreatment of abortion by misoprostol |
- Complete abortion [ Time Frame: 1week ]Complete abortion (complete expulsion of products of conception with no need for curettage) within one week from the first dose of misoprostol.
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| Ages Eligible for Study: | 18 Years to 35 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Study Settings:
This clinical trial will be conducted in department of obstetrics and gynecology at Zagazig General Hospital during the period between January 2019 and June 2019.
Study Population:
The patients will be recruited from women attending outpatient clinic of obstetrics or the emergency room of Zagazig General Hospital.
Inclusion Criteria:
- Woman age more than 18 years old (age of legal consent).
- BMI ranges between 25 kg/m2 and 35 kg/m2.
- Gestational age of 63 days' gestation (or less).
- Missed abortion.
- Hemoglobin leve
Exclusion criteria:
- Woman age less than 18 years old.
- BMI less than 25 kg/m2 or more than 35 kg/m2.
- Gestational age more than 63 days' gestation.
- Molar pregnancy.
- Hemoglobin level less than 10 gm/dL.
- Fibroid uterus.
- Uterus with congenital anomalies.
- Previous attempts for induction of abortion in the current pregnancy.
- Coagulation defect i.e. coagulopathy.
- Contraindication for induction of abortion e.g. heart failure.
- Allergy to misoprostol or letrozole.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04593108
| Egypt | |
| Dalia Mohammed Al Sayed Zaki | |
| Zagazig, Sharqia, Egypt, 1436 | |
| Principal Investigator: | Zagazig General hospital, Ministry hospital | Zagazig general hospital |
Study Data/Documents: Individual Participant Data Set
Albrecht ED, Aberdeen GW, Pepe GJ, (2000). The role of estrogen in the maintenance of primate pregnancy. Am J Obstet Gynecol. 182:432-8.
Albrecht ED, Robb VA, Pepe GJ, (2004). Regulation of placental vascular endothelial growth permeability factor expression and angiogenesis by estrogen during early baboon pregnancy. J Clin Endocrinol Metab. 89:
Publications of Results:
| Responsible Party: | Dr.Dalia Mohammed Al Sayed Zaki, Banha university, Benha University |
| ClinicalTrials.gov Identifier: | NCT04593108 |
| Other Study ID Numbers: |
Treatment of missedmiscarriage |
| First Posted: | October 19, 2020 Key Record Dates |
| Last Update Posted: | October 20, 2020 |
| Last Verified: | October 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Abortion, Missed Abortion, Spontaneous Pregnancy Complications Letrozole Misoprostol Antineoplastic Agents Aromatase Inhibitors Steroid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Anti-Ulcer Agents Gastrointestinal Agents Oxytocics |