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Effect of the Length of Second Stage of Labor in Primigravidae on Maternal & Neonatal Outcomes (RCT)

2016年2月4日 更新者:Mohamed El-Sharkawy、Kasr El Aini Hospital
The primary purpose of this study is to compare the effects of two different methods of care during the second stage of labor for nulliparous women (coached versus uncoached pushing) on the length of the second stage and how this may affect maternal and neonatal outcome.

調査の概要

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:

  1. Careful and detailed history taking regarding:

    • Personal history
    • Complaint.
    • History of present pregnancy.
    • Menstrual History.
    • Past history.
  2. Careful general examination.
  3. Abdominal examination.
  4. Local vaginal examination.
  5. 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:

  1. 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
  2. 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.
  3. Third stage of labor:

    - Duration of the third stage.

  4. Assessment of any vaginal laceration or perineal tears with their repair as well as repair of episiotomy.
  5. Assessment of quantity of blood loss and assessment of uterine atony(vital instability,number of soaked pads and hemoglobin drop) .
  6. Rate of caesarean section during varying stages of labor.
  7. Neonatal assessment:

It includes:

  • Foetal sex and body weight.
  • APGAR score at 1 and 5 minutes..

研究の種類

観察的

入学 (予想される)

434

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~35年 (大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

女性

サンプリング方法

確率サンプル

調査対象母集団

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.

説明

Inclusion Criteria:

All patients admitted in the first stage of labor with cervical dilatation of 4 cm at least:

  1. Women age 18-35 years.
  2. 37-41 weeks gestation pregnancy.
  3. Singleton pregnancy and vertex presentation.
  4. Women have no chronic or pregnancy-induced illnesses.
  5. Women are in established, spontaneous labor.

Exclusion Criteria:

  1. Malpresentation.
  2. Women with previous uterine scar.
  3. Multiple pregnancy
  4. Ante partum hemorrhage.
  5. Cephalopelvic disproportion.
  6. Women have chronic illnesses.
  7. Women with abnormal antenatal period.
  8. Patients with foetal distress
  9. Premature rupture of membrane
  10. Woman having any contraindication to vaginal delivery.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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

ここでは、この調査に関係する人々や組織を見つけることができます。

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

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2015年11月1日

一次修了 (予想される)

2016年5月1日

研究の完了 (予想される)

2016年5月1日

試験登録日

最初に提出

2015年11月20日

QC基準を満たした最初の提出物

2016年2月4日

最初の投稿 (見積もり)

2016年2月8日

学習記録の更新

投稿された最後の更新 (見積もり)

2016年2月8日

QC基準を満たした最後の更新が送信されました

2016年2月4日

最終確認日

2016年2月1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

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