Effect of the Length of Second Stage of Labor in Primigravidae on Maternal & Neonatal Outcomes (RCT)
調査の概要
状態
詳細な説明
The study was conducted on 434 primigravidae women admitted to Kasr El Ainy teaching Maternity Hospital for labor. The study will be done in the period between October 2015 and April 2016. The study will include 434 women with the diagnosis of the first stage of labor with at least cervical dilatation 4cm.
Ethical approval obtained and an informed consent will be taken from each patient after explaining the nature and scope of the study.
Methodology in details:
Careful and detailed history taking regarding:
- Personal history
- Complaint.
- History of present pregnancy.
- Menstrual History.
- Past history.
- Careful general examination.
- Abdominal examination.
- Local vaginal examination.
- Ultrasound examination.
Management of Cases:
Group (I)(Coached group):
It includes 217 patients who are admitted in active stage of labor (cervical dilatation 4cm at least) to labor delivery ward. They are coached by the nurse to use closed-glottis and pushing three to four times during each contraction immediately when cervical dilation reached 10 cm and to continue pushing using this method with each contraction until birth. The nurse counts to 10 during each pushing effort to assist the woman in holding her breath for at least 10 seconds.
Group (II)(Uncoached group):
It includes 217 patients who are admitted early in active stage of labor (cervical dilatation 4cm at least) to labor delivery ward at 10-cm cervical dilation where they remain until they feel the urge to push or the second stage had lasted 2 hours (whichever came first)., they are encouraged to bear down with contractions without holding their breath (open-glottis) for no more than 6-8 seconds and continue bearing down no more than three times with each contraction until birth. .
Patients admitted early in labor are subjected to active management of labor as follows:
Pelvic examination performed. Routine amniotomy performed and progress assessed. When dilatation is not increasing, a low dose protocol of oxytocin infusion will be started. Oxytocin diluted in the form of 5IU in 500 ml Ringer lactate making a concentration of nearly 1mu oxytocin/1ml Ringer solution. Infusion instituted at a rate of 1 -2 milliunit (15-30 drops) per minute and increased gradually in increments of 1 -2 milliunit per minute at 30 minutes interval, until at least three uterine contractions noted in a 10 minute period using cardio tocograph.
Assessment of each stage of labor was performed as follow:
First stage of labor:
It includes:
- Duration of the first stage of labor.
- Rate of cervical dilatation and foetal descent.
- Adequacy of uterine contractions and documentation of labor dystocia.
- Excess uterine activity consisted of uterine tachysystole, hypertonus or uterine hyperstimulation
Second stage of labor:
It includes:
- Duration of the second stage.
- Rate of the descent of foetus.
- Monitoring of foetal heart rate every 5 minutes by sonicaid or continuous by CTG.
- Use of mediolateral episiotomy.
- Intervention will be considered either by instrumental delivery,fundal pressure or by CS If the second stage is prolonged more than 2 hours.
- Monitoring of maternal oxygen saturation by pulse oximeter.
Third stage of labor:
- Duration of the third stage.
- Assessment of any vaginal laceration or perineal tears with their repair as well as repair of episiotomy.
- Assessment of quantity of blood loss and assessment of uterine atony(vital instability,number of soaked pads and hemoglobin drop) .
- Rate of caesarean section during varying stages of labor.
- Neonatal assessment:
It includes:
- Foetal sex and body weight.
- APGAR score at 1 and 5 minutes..
研究の種類
入学 (予想される)
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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
All patients admitted in the first stage of labor with cervical dilatation of 4 cm at least:
- Women age 18-35 years.
- 37-41 weeks gestation pregnancy.
- Singleton pregnancy and vertex presentation.
- Women have no chronic or pregnancy-induced illnesses.
- Women are in established, spontaneous labor.
Exclusion Criteria:
- Malpresentation.
- Women with previous uterine scar.
- Multiple pregnancy
- Ante partum hemorrhage.
- Cephalopelvic disproportion.
- Women have chronic illnesses.
- Women with abnormal antenatal period.
- Patients with foetal distress
- Premature rupture of membrane
- Woman having any contraindication to vaginal delivery.
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
- 観測モデル:ケースコントロール
- 時間の展望:見込みのある
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
1
Group (I)(Coached group): It includes 217 patients who are admitted in active stage of labor (cervical dilatation 4cm at least) to labor delivery ward. They are coached by the nurse to use closed-glottis and pushing three to four times during each contraction immediately when cervical dilation reached 10 cm and to continue pushing using this method with each contraction until birth. The nurse counts to 10 during each pushing effort to assist the woman in holding her breath for at least 10 seconds. |
It includes 217 patients who are admitted in active stage of labor (cervical dilatation 4cm at least) to labor delivery ward.
They are coached by the nurse to use closed-glottis and pushing three to four times during each contraction immediately when cervical dilation reached 10 cm and to continue pushing using this method with each contraction until birth.
The nurse counts to 10 during each pushing effort to assist the woman in holding her breath for at least 10 seconds.
|
|
2
It includes 217 patients who are admitted early in active stage of labor (cervical dilatation 4cm at least) to labor delivery ward at 10-cm cervical dilation where they remain until they feel the urge to push or the second stage had lasted 2 hours (whichever came first)., they are encouraged to bear down with contractions without holding their breath (open-glottis) for no more than 6-8 seconds and continue bearing down no more than three times with each contraction until birth.
|
It includes 217 patients who are admitted early in active stage of labor (cervical dilatation 4cm at least) to labor delivery ward at 10-cm cervical dilation where they remain until they feel the urge to push or the second stage had lasted 2 hours (whichever came first)., they are encouraged to bear down with contractions without holding their breath (open-glottis) for no more than 6-8 seconds and continue bearing down no more than three times with each contraction until birth. .
|
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 |
|---|---|
|
Duration of the second stage
時間枠:0-3 hours
|
0-3 hours
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Severe maternal morbidity e.g post partum hemorrhage
時間枠:intrapartum and 2 hours postpartum.
|
intrapartum and 2 hours postpartum.
|
|
APGAR score after one and five minutes.
時間枠:1-5 minutes
|
1-5 minutes
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター:Kasr El Ainy, hospital、kasr el ainy street,cairo,egypt
研究記録日
主要日程の研究
研究開始
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
その他の研究ID番号
- KasrELAini maternity hospital
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。