Fertility and Obstetric Outcomes After Medical Management Versus Surgical Treatment for First-trimester Miscarriage First-trimester Miscarriage
Fertility and Obstetric Outcomes After Medical Management Versus Surgical Treatment for First-trimester Miscarriage
Study Objective: To compare the time to new pregnancy and pregnancy outcomes in women who received Misoprostol for uterus evacuation versus those treated surgically with dilatation and curettage.
Study Population: Women to be admitted to the Lis maternity department for first trimester failed pregnancy. Patients will choose between medical versus surgical management. Of this group, women interested and successful in achieving a new pregnancy without first engaging in birth control methods will be included in our study.
Inclusion Criteria: Women with first trimester failed pregnancy (up until week 12 according to LMP and up to CRL compatible with 11 gestational weeks) Exclusion Criteria: Women under the age of 18 or over the age of 45, women who conceived via fertility treatments, women with a molar pregnancy.
Study Type: prospective study. Study Description: Women who visit the emergency department or gynecology clinic with a first-trimester miscarriage will be questioned regarding their subsequent family planning. In the event that the woman is interested in another pregnancy, and is not planning to use birth control methods prior to conception, the use of folic acid will be recommended, and she will receive an explanation of the research process. Women who agree to participate in the study orally and who sign a written consent form will be included in the study.
Three to six months following uterine evacuation, study participants will receive a telephone call to assess whether they have conceived, and the case that they had not yet conceived, will receive a follow-up call after an additional three to six months.
Each woman who conceived, will receive a follow-up call to assess the details of the birth. In the event that she did not give birth in the Lis Maternity Hospital, she will be asked to fax a copy of the release letter she received from the hospital.
Type of Birth: Normal vaginal delivery, operative delivery, cesarean section. Birth details will be collected via the automated system in Lis in the event that the birth took These women will be included in the study and will be divided into two groups: surgical vs. medical management. The study will include roughly 200 women in each of the two groups.
It will be clarified that:
- The researcher will confirm the identity of the participant at the outset of the telephone call.
- The researcher will request consent and introduce him or herself as a member of the research team from the Lis Hospital. In the event of refusal to participant, the research will apologize and terminate the telephone call.
Study Parameters: 1 .Demographic Parameters of the two groups - age, gravity, parity, ethnicity, history of infertility.
2. Comparison of the success of the surgical treatment versus medical management - in this case, failure is defined as the need for subsequent surgical treatment. This will include data on the percentage of women who received multiple doses of Misoprostol.
3. A comparison of the time (in months) until a new pregnancy is conceived (from the data of the dilatation and curettage or the first dose of the Misoprostol) 4. Pregnancy Outcomes - first trimester miscarriage, obstetric outcomes, early deliveries, pregnancy complications - IUGR, placental abruption, pre-eclampsia, cesarean sections, neonatal outcomes. This data will be collected in multiple telephone conversations - three months after conception and following the delivery date.
- Validation of details of pregnancies that ended in miscarriage - was the pregnancy desired? Mode of conception (if fertility treatments - which?), months until conception, gestational age at the time that a non-viable pregnancy was diagnosed, mode of pregnancy termination. The details will be validated in relation to details in our automated system.
- At what month did the woman resume menstruation? Was an ultrasound performed to assess uterine evacuation prior to a new pregnancy conception?
- Details on pregnancy following dilatation and curettage - time to conception from pregnancy termination, pregnancy outcomes, gestational age at birth (or miscarriage), birth weight, Apgar scores, pH (if available).
- Data on fertility, age, obstetric history, time to conception of new pregnancies, need for fertility treatments.
Mechanism of Anonymity:
The primary researcher will be responsible for the removal of identifying data. After this data has been removed, in the event that it is still necessary to complete data on the participants, we will make contact with the participant and he will sign a telephone consent form regarding this data completion. In the event that no data is mission and/or after the data is completed through a telephone call, the identifying details will be removed in a way that it will be impossible to replace them. And the telephone consent forms will be saved in a cabinet that can be accessed only by the primary and secondary researchers.
調査の概要
研究の種類
入学 (予想される)
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Criteria: Women with first trimester failed pregnancy
Exclusion Criteria:
- Women under the age of 18 or over the age of 45, women who conceived via fertility treatments, women with a molar pregnancy
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:非ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の:drug treatment
Misoprostol for uterine evacuation
|
mentioned above
|
|
他の:surgical treatment
dilatation and curettage for uterine evacuation
|
mentioned above
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Time from evacuation of the uterus to new conception
時間枠:2 years
|
2 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
pregnancy outcome
時間枠:2 years
|
abortion/preterm labor/ term labor
|
2 years
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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